Robotic Sample Preparation System For Diagnostic Testing With Automated Position Learning

ABSTRACT

An automated apparatus can provide pre-analytical processing of samples, racking and forwarding to an adjacent analyzer for analysis. The apparatus may have a controller that implements an auto-learn process to teach robotic handlers the locations within the workspace(s) of the apparatus. A robotic sample handler may include a sensor configured to generate a detection signal when in a near vicinity of a fiducial beacon in the workspace of the apparatus for biological sample preparation, preprocessing and/or diagnostic assay performed by one or more analyzers of the automated apparatus. The controller may control the robotic sample handler to conduct a search pattern so that a location of the fiducial beacon may be detected and thereafter calculated to obtain a more accurate location of the beacon. The calculated positions may then serve as a basis for the controlled movement of samples by the robot to and from locations of the workspace.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of Application Ser. No.62/729,531 filed Sep. 11, 2018, the disclosure of which is incorporatedherein by reference.

BACKGROUND OF THE INVENTION

Diagnostic testing of biological samples is instrumental in the healthcare industry's efforts to quickly and effectively diagnose and treatdisease. Clinical laboratories that perform such diagnostic testingalready receive hundreds or thousands of samples on a daily basis withan ever increasing demand. The challenge of managing such largequantities of samples has been assisted by the automation of sampleanalysis. Automated sample analysis is typically performed by automatedanalyzers that are commonly self-contained systems which performmultistep processes on the biological samples to obtain diagnosticresults.

Several current automated clinical analyzers offer a user an array ofautomated tests that can be performed on a provided sample.Pre-analytical systems meant to help prepare a sample for analysis by ananalyzer also exist. In some pre-analytical systems, the systems mayautomatically transfer an aliquot of sample between several containers.The samples also need to be moved from the pre-analytical system to theanalyzer and from the analyzer to a storage location once analysis iscomplete.

One or more robot(s) may be utilized in such systems for movingsample(s), such as in particular container(s), into and out of variouspositions of the various components of the system. For example, agripper of a gripper robot may carry a sample in a container to aparticular storage position of a rack where a sample may sit idle, suchas for an incubation time or to wait to go from the pre-analyzer to theanalyzer. Most such robots are taught the coordinates for variouspositions within such as system, such as by manually calibrating a mapof locations or a particular location from which other locations of apredetermined map may be derived. With manual calibration, a humanoperator controls the movement of the robot to a desired location andupon observing a proper location, the encoder positions of the motors ofthe robot may be manually entered into the controller for use insubsequently moving the robot in the workspace relative to the manuallylearned locations. With the frequent need to calibrate due to operationsand repairs, such human involved system calibration is less desirable.In some cases, robots with contact/touch sensors may automatically movein a workspace and bump-sense locations in the workspace for determininga desired location within the workspace. Such bump-sense devices requirefixed structures in the workspace so that the robot can move to makecontact with the fixed structure. They also require force sensors fordetecting the collision of the sensor and the fixed structure. Suchcollisions can in some cases serve to de-calibrate motors if sensing ofthe force of the contact and stopping of the motors associated withmovement of the robot are not carefully controlled.

Improved methods for automatically calibrating locations of a workspaceof such systems may be desired such as to avoid such sensingcomplexities.

BRIEF SUMMARY OF THE INVENTION

The present disclosure describes devices, systems, and methods forautomatically teaching robotic manipulators positions of a workspaceparticularly in apparatus for biological sample preparation,preprocessing and/or diagnostic assay performed by one or more analyzersof the apparatus.

Some versions of the present technology include an apparatus forbiological sample preparation, preprocessing and/or diagnostic assayperformed by one or more analyzers of the apparatus. The apparatus mayinclude a fiducial beacon within a workspace of an automated apparatusfor biological sample preparation, preprocessing and/or diagnostic assayperformed by one or more analyzers of the automated apparatus. Theapparatus may include a robotic sample handler comprising a first motorand a second motor for moving the robotic sample handler in theworkspace. The apparatus may include a sensor configured to generate afield detection signal when in a near vicinity of the fiducial beacon,the sensor adapted to couple with the robotic sample handler. Theapparatus may include a controller, comprising at least one processor.The controller may be configured to operate the first and second motorsto move the robotic sample handler in the workspace. The controller maybe configured to move the robotic sample handler in the workspace in asearch pattern. The search pattern may include first movement along afirst axis in a first direction. The search pattern may further includea second movement along the first axis in a second direction. The seconddirection may be opposite the first direction. The controller may befurther configured with a sensing module to, during the search pattern,(a) receive, via the sensor, the field detection signal produced in anear vicinity of the fiducial beacon, and (b) to determine a first counton the first axis correlating with a location of a first detection ofthe fiducial beacon during the first movement, and (c) to determine asecond count on the first axis correlating with a location of a seconddetection of the fiducial beacon during the second movement. Thecontroller may be further configured with a position calculating moduleto calculate a third count on the first axis based on the first countand the second count. The third count may correlate with a location ofthe fiducial beacon on the first axis.

In some versions of the apparatus, the search pattern controlled by thecontroller may further include third movement along a second axis in athird direction, the search pattern further comprising a fourth movementalong the second axis in a fourth direction, the fourth directionopposite the third direction. The controller with the sensing module maybe further configured to (a) determine a fourth count on the second axiscorrelating with a location of a third detection of the fiducial beaconduring the third movement, (b) determine a fifth count on the secondaxis correlating with a location of a fourth detection of the fiducialbeacon during the fourth movement. The controller with the positioncalculating module may be further configured to calculate a sixth counton the second axis based on the fourth count and the fifth count, thesixth count correlating with a location of the fiducial beacon on thesecond axis.

Optionally, the third count and the sixth count may correspond to x andy coordinates respectively of the location of the fiducial beacon in theworkspace. The controller may be further configured to control movingthe robotic sample handler to predetermined locations in the workspaceof the automated apparatus based on the x and y coordinates of thelocation of the fiducial beacon in the workspace. The third count may bea first average count calculated by averaging the first count and thesecond count and the sixth count may be a second average countcalculated by averaging the fourth count and the fifth count.

The search pattern may include a detection of a plurality of fiducialbeacons in the workspace and the controller may be configured tocalculate coordinates of locations of the plurality of fiducial beacons.The controller may be further configured to control moving, via thecontroller, the robotic sample handler to predetermined locations in theworkspace of the automated apparatus based on the calculated coordinatesof the locations of the plurality of fiducial beacons in the workspace.In some versions, the first count and the second count may be producedby a first encoder of the first motor. The fourth count and the fifthcount may be produced by a second encoder of the second motor. Thefiducial beacon may produce a magnetic field. The fiducial beacon mayinclude a magnetic. The sensor may be a Hall-effect sensor. The roboticsample handler may be a gripper. The sensor may be adapted as aremoveable sensor for insertion into the gripper during the searchpattern.

Some versions of the present technology may include a processor-readablemedium, having stored thereon processor-executable instructions which,when executed by a processor, cause the processor to control operationof a controller of a robotic handler. The robotic handler may include asensor configured to generate a field detection signal when in a nearvicinity of a fiducial beacon in a workspace of an automated apparatusfor biological sample preparation, preprocessing and/or diagnostic assayperformed by one or more analyzers of the automated apparatus. Theprocessor-executable instructions may comprise a control moduleconfigured to control moving, via the controller, the robotic handler inthe workspace of the automated apparatus. The moving may include asearch pattern including first movement along a first axis in a firstdirection. The search pattern may further include second movement alongthe first axis in a second direction, the second direction opposite thefirst direction. The processor-executable instructions may comprise asensing module configured to control, during the search pattern,receiving, via the sensor coupled to the robotic handler, the fielddetection signal produced in a near vicinity of the fiducial beacon, thesensing module configured to determine a first count on the first axiscorrelating with a location of a first detection of the fiducial beaconduring the first movement, the sensing module further configured todetermine a second count on the first axis correlating with a locationof a second detection of the fiducial beacon during the second movement.The processor-executable instructions may comprise a positioncalculating module configured to calculate a third count on the firstaxis based on the first count and the second count, the third countcorrelating with a location of the fiducial beacon on the first axis.

In some versions, the search pattern controlled by the control modulemay further include third movement along a second axis in a thirddirection. The search pattern may further include fourth movement alongthe second axis in a fourth direction, the fourth direction opposite thethird direction. The sensing module may be further configured todetermine a fourth count on the second axis correlating with a locationof a third detection of the fiducial beacon during the third movement.The sensing module may be further configured to determine a fifth counton the second axis correlating with a location of a fourth detection ofthe fiducial beacon during the fourth movement. The position calculatingmodule may be further configured to calculate a sixth count on thesecond axis based on the fourth count and the fifth count, the sixthcount correlating with a location of the fiducial beacon on the secondaxis.

The third count and the sixth count may correspond to x and ycoordinates respectively of the location of the fiducial beacon in theworkspace. The control module may be further configured to controlmoving, via the controller, the robotic handler to predeterminedlocations in the workspace of the automated apparatus based on the x andy coordinates of the location of the fiducial beacon in the workspace.The third count may be a first average count calculated by averaging thefirst count and the second count. The sixth count may be a secondaverage count calculated by averaging the fourth count and the fifthcount. The search pattern may include a detection of a plurality offiducial beacons in the workspace. The position calculating module maybe configured to calculate coordinates for locations of the plurality offiducial beacons. The control module may be further configured tocontrol moving, via the controller, the robotic handler to predeterminedlocations in the workspace of the automated apparatus based on thecalculated coordinates of locations of the plurality of fiducial beaconsin the workspace.

The first count and the second count may be produced by a first encoderof a first motor controlled by the controller that is configured to movethe robotic handler in the workspace. The fourth count and the fifthcount may be produced by an encoder of a second motor controlled by thecontroller that is configured to move the robotic handler in theworkspace. The fiducial beacon may be configured to produce a magneticfield. The fiducial beacon may include a magnetic to produce themagnetic field. The sensor may be a Hall-effect sensor.

Some versions of the present technology may include a method of acontroller to control operation of a robotic handler. The robotichandler may include a sensor configured to generate a field detectionsignal when in a near vicinity of a fiducial beacon in a workspace of anautomated apparatus for biological sample preparation, preprocessingand/or diagnostic assay performed by one or more analyzers of theautomated apparatus. The method may include controlling moving of therobotic handler in the workspace of the automated apparatus in a searchpattern. The search pattern may include first movement along a firstaxis in a first direction. The method may include sensing, during thefirst movement of the search pattern, so as to receive, via the sensorcoupled to the robotic handler, the field detection signal produced in anear vicinity of the fiducial beacon, and to determine a first count onthe first axis correlating with a location of a first detection of thefiducial beacon during the first movement. The method may includecontrolling moving of the robotic handler in the workspace of theautomated apparatus in the search pattern. The search pattern mayinclude a second movement along the first axis in a second direction,the second direction opposite the first direction. The method mayinclude sensing, during the second movement of the search pattern, so asto receive, via the sensor coupled to the robotic handler, the fielddetection signal produced in a near vicinity of the fiducial beacon, andto determine a second count on the first axis correlating with alocation of a second detection of the fiducial beacon during the secondmovement. The method may include calculating a third count on the firstaxis based on the first count and the second count. The third count maycorrelate with a location of the fiducial beacon on the first axis.

The method may further include controlling moving of the robotic handlerto one or more predetermined locations in the workspace of the automatedapparatus based on the calculated third count correlating with thelocation of the fiducial beacon in the workspace.

Other features of the technology will be apparent from consideration ofthe information contained in the following detailed description,drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The features, aspects, and advantages of the present invention willbecome better understood with regard to the following description,appended claims, and accompanying drawings in which:

FIG. 1A is a front perspective view of a pre-analytical system accordingto one embodiment of the present disclosure.

FIG. 1B is a schematic representation of the pre-analytical system ofFIG. 1A in an exemplary application within a hub-and-spoke distributionnetwork.

FIG. 2 is another front perspective view of the pre-analytical system ofFIG. 1A.

FIG. 3 is a rear perspective view of the pre-analytical system of FIG.1A.

FIG. 4A is a top perspective view of a sample container rack accordingto one embodiment of the present disclosure.

FIG. 4B is a bottom perspective view of the sample container rack ofFIG. 4A.

FIG. 4C is another bottom perspective view of the sample container rackof FIG. 4A and an engagement member thereof.

FIG. 5 is a top perspective view of a sample container rack according toanother embodiment of the present disclosure.

FIG. 6 is a top perspective view of a sample container rack according toa further embodiment of the present disclosure.

FIG. 7 is a top view of sample pre-analytical processing decks of theanalytical system of FIG. 1A.

FIG. 8A is a perspective view of a sample conversion module of one ofthe sample pre-analytical processing decks of FIG. 7 according to oneembodiment of the present disclosure.

FIG. 8B is a perspective view of a tube clamp assembly of the sampleconversion module of FIG. 8A according to one embodiment of the presentdisclosure.

FIG. 8C is a schematic view of a diluent dispense system of the sampleconversion module of FIG. 8A according to one embodiment of the presentdisclosure.

FIG. 9 is a front perspective view of a bulk vortexer according to oneembodiment of the present disclosure.

FIG. 10 is a front perspective view of a warmer of one of the samplepre-analytical processing decks of FIG. 7 according to one embodiment ofthe present disclosure.

FIG. 11 is a front perspective view of a cooler of one of the samplepre-analytical processing decks of FIG. 7 according to one embodiment ofthe present disclosure.

FIG. 12A is a front perspective view of a shuttle handling assembly ofthe pre-analytical system of FIG. 1A according to one embodiment of thepresent disclosure.

FIG. 12B is a shuttle of the shuttle handling assembly of FIG. 12Aaccording to one embodiment of the present disclosure.

FIG. 12C is a partial rear perspective view of the shuttle handlingassembly of FIG. 12A.

FIG. 12D is a perspective view of a shuttle docking station including ashuttle clamping mechanism.

FIG. 12E is a perspective view of an angled elevator according to anembodiment of the present disclosure.

FIG. 13 is a shuttle transport assembly of the pre-analytical system ofFIG. 1A according to one embodiment of the present disclosure.

FIG. 14A is a front perspective view of a rack handler robot of thepre-analytical system of FIG. 1A according to one embodiment of thepresent disclosure.

FIG. 14B is a top enhanced view of a carriage of the rack handler robotof FIG. 14A including a rack mover arm.

FIG. 14C is a side enhanced view of the rack mover arm of FIG. 14B.

FIG. 14D is a top perspective view of the rack mover arm of FIG. 14B inan intermediate position.

FIG. 14E is a top perspective view the rack mover arm of FIG. 14B in aback position.

FIG. 14F is a bottom perspective view of the rack mover arm of FIG. 14Bin front position and in relation to the sample rack container rack ofFIG. 4A.

FIGS. 14G and 14H show the rack mover arm of FIG. 14B moving a samplerack container from a back position to a front position.

FIG. 15 is a front perspective view of a rack elevator of thepre-analytical system of FIG. 1A according to one embodiment of thepresent disclosure.

FIG. 16A is a front perspective view of a suspended robot assembly ofthe pre-analytical system of FIG. 1A according to one embodiment of thepresent disclosure.

FIG. 16B is a rear perspective view of a pick and place robot of thesuspended robot assembly of FIG. 16A according to one embodiment of thepresent disclosure.

FIG. 16C is a rear perspective view of a decapper robot of the suspendedrobot assembly of FIG. 16A according to one embodiment of the presentdisclosure.

FIG. 17A is a front view of a pipette assembly of a pipette head of thesample handling assembly of FIG. 16A according to one embodiment of thepresent disclosure.

FIG. 17B is a cross-sectional view taken at line D-D of FIG. 17A.

FIG. 17C is a side view of the pipette assembly of FIG. 17A.

FIG. 17D is a cross-sectional view taken at line F-F of FIG. 17C.

FIG. 18 is a top view of the preparation/processing decks of FIG. 8Aschematically representing the operating envelope of the robots of thesupport beam robot assembly of FIG. 16A.

FIG. 19 is a top view of the preparation/processing decks of FIG. 8Aschematically representing various modules of the pre-analytical systemof FIG. 1A.

FIG. 20 is a block diagram of an example architecture of a computingsystem involving the pre-analytical system of FIG. 1A including examplecomponents suitable for implementing methodologies of the presentdisclosure.

FIG. 21 is a flow diagram of a method of using the pre-analytical systemof FIG. 1A according to one embodiment of the present disclosure.

FIGS. 22A-G are embodiments of workflows that are supported by thepre-analytical system

FIG. 23 is side perspective view of an optional single containertransport according to another pre-analytical system embodiment of thepresent disclosure.

FIG. 24A is a front perspective view of an optional sample tuberetention assembly according to one embodiment of the presentdisclosure.

FIG. 24B is a top view of the sample tube retention assembly of FIG.24A.

FIG. 24C is a side view of the sample tube retention assembly of FIG.24C in a first position.

FIG. 24D is a side view of the sample tube retention assembly of FIG.24C in a second position.

FIG. 25A is a front view of a pipette head according to anotherembodiment of the present disclosure.

FIG. 25B is a front transparent view of the pipette head according toFIG. 25A.

FIG. 25C is a rear perspective view of the pipette head of FIG. 25A in afirst position relative to a pipette assembly carriage.

FIG. 25D is a rear perspective view of the pipette head of FIG. 25A in asecond position relative to a pipette assembly carriage.

FIG. 26 is a block diagram of an illustrative architecture of acomputing system according to another embodiment of the presentdisclosure.

FIG. 27 is a front, partial cutaway view of a pipette head according toa further embodiment of the present disclosure.

FIGS. 28A and 28B are alternating rear perspective views of a backplaneconnector connected to the pipette head of FIG. 27.

FIG. 29 is a perspective views of a backplane connector connected to thepipette head of FIG. 27.

FIGS. 30A-E illustrate a tray for receiving consumables that permitseasy transition of the consumables into a rack configured to be receivedby the system described herein.

FIGS. 31A-31C are perspective views of a decapper assembly according toanother embodiment of the present disclosure.

FIG. 31D is a bottom view of the decapper assembly of FIG. 31A.

FIG. 31E is a sectional view of the decapper assembly of FIG. 31A takenalong a midline thereof.

FIG. 31F is another perspective view of the decapper assembly of FIG.31A.

FIGS. 31G is an exploded elevational view of a gripper assembly of thedecapper assembly of FIG. 31A.

FIG. 31H is a perspective exploded view of the gripper assembly of FIG.31G.

FIG. 31I is a sectional view of the gripper assembly of FIG. 31G.

FIG. 31J is a sample container array depicting gripper finger pick-uppositions.

FIG. 31M is a perspective view of a sample container contact sensorassembly of the decapper assembly of FIG. 31A.

FIG. 31N is a perspective view of a plunger cap of the sensor assemblyof FIG. 31M.

FIG. 32A is a perspective view of a batch warmer array according to anfurther embodiment of the present disclosure.

FIG. 32B is a sectional view of a batch warmer taken along a midlinethereof.

FIG. 32C is a top-down sectional view of a batch warmer taken directlyabove a heater thereof.

FIGS. 33A and 33B are perspective views of a cooler according to afurther embodiment of the present disclosure.

FIG. 34 shows example components of a controller for an auto-learnprocess to permit automatic positioning calibration of a robotic samplehandler in a workspace of the robot.

FIG. 35 is an example flow chart of steps of an auto-learn process forlearning fiducial beacon location(s) in a workspace of a robotic samplehandler.

FIG. 36 is an illustration showing an example detection flow for theauto-learn process of FIG. 35.

DETAILED DESCRIPTION Definitions

As used herein, “primary sample container” means any container in whicha sample, such as a biological sample, as it is received by thepre-analytical system. In addition, “secondary sample container” isintended to mean any container that holds a sample after beingtransferred out of the primary sample container. In some examples“primary sample container” refers to those containers that can behandled directly by the pre-analytical system described herein withoutthe need to transfer the sample from the primary container to asecondary container. As used herein, the terms “about,” “generally,” and“substantially” are intended to mean that slight deviations fromabsolute are included within the scope of the term so modified.

The term “shuttle” as used herein broadly includes any structure thatcan carry a plurality of sample containers and has a plurality ofreceptacles, each configured to receive a single sample container.Conventional other terms that can be used to describe the shuttleinclude, for example, racks, conveyance, carrier, etc.

Also when referring to specific directions, such as left, right, front,back, up and down, in the following discussion, it should be understoodthat such directions are described with regard to the perspective of auser facing the below described system during exemplary operation.

System Generally

FIGS. 1A-3 depict the general structure and layout of a pre-analyticalsystem 10 according to one embodiment of the present disclosure. Asillustrated in FIG. 1B, system 10 is configured to act as a hub in ahub-and-spoke distribution network involving a user and one or moreanalyzers A₁ . . . A_(n), such as the BD Viper™ LT System (BectonDickinson, Franklin Lakes, N.J. or the BD MAX™ System). System 10 is ahigh-throughput platform that automates sample preparation andpreprocessing for any number of analytical tests or assays performed bythe one or more analyzers. For example, system 10 can prepare andpreprocess samples for assays involving the determination of blood viralloads and the detection of human papilloma virus (HPV), Chlamydiatrachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, group Bstreptococcus, enteric bacteria (e.g., Campylobacter, Salmonella,Shigella, Escherichia coli, Shigella dysenteriae), and enteric parasites(e.g., Giardia lamblia, Cryptosporidium, Entamoeba histolytica). System10 is also capable of preparing and preprocessing several categories ofsamples including blood, mucus, sputum, urine, feces, liquid basedcytological samples and the like.

Sample Containers

In addition, system 10 can accommodate a variety of sample containersincluding, but not limited to, ThinPrep® cervical sample/liquid basedcytology containers (Hologic, Inc., Bedford, Mass.), SurePath™ cervicalsample/liquid based cytology containers (Becton Dickinson, FranklinLakes, N.J.), blood sample containers and blood collection containerssuch as, for example, BD Vacutainer® blood collection tubes, andpenetrable-cap containers, such as BD MAX™ sample buffer tubes withpierceable caps (Becton Dickinson, Franklin Lakes, N.J.) and APTIMA®Transport Tubes (Gen-Probe Inc., San Diego, Calif.).

For simplicity, the remainder of this disclosure refers to first-type,second-type, and third-type sample containers 01, 02, and 03. Exemplaryfirst-type, second-type, and third-type containers 01, 02, 03 aredepicted in FIG. 8A. First type containers 01 are analogous to ThinPrep®containers, second type containers 02 are analogous to SurePath™containers, and third type containers 03 are analogous to BD MAX™ mLsample buffer tubes. The ThinPrep® containers and SurePath™ containersare referred to collectively as liquid based cytology (LBC) containers.Each of these types of containers differs in size such that thefirst-type 01 is the largest and the third-type 03 is the smallest.However, this particular size distribution is not necessary and is onlymeant to be illustrative of the container handling capabilities ofsystem 10. As such, it should be understood that the first-type,second-type, and third-type containers 01, 02, 03 may be the same sizeor differ in size other than what is described directly above. Inaddition, third-type sample container 03 is particularly adapted for useby the one or more analyzers that can be coupled to system 10. Forexample, third-type sample container 03 may have a penetrable cap, suchas a cap having a foil septum, or some other cap or structural featureparticularly suited for use in the one or more analyzers A₁ . . . A_(n).

These containers are also referred to as primary first-type container01, primary second-type container 02, and primary third-type container03. These descriptions refer to containers 01, 02, and 03 in the role ofa primary sample container. In addition, third-type container 03 isoccasionally referred to as secondary third-type container 03, whichrefers to the third-type container's role as a secondary samplecontainer.

System Frame

System 10 includes a structural frame 20 comprised of several supportcomponents 21, such as segments of metal tubing, which are configured tosupport and define various decks or levels for pre-analyticalpreparation and preprocessing of samples. Such decks or levels include amain storage deck or first accumulation area 22, a first pre-analyticalprocessing deck 24, a second pre-analytical processing deck 26, and asuspended robot deck 28.

System Deck Relationships

Main storage deck 22 is generally the lowest located deck. It is definedat an upper boundary by first and second decks 24, 26. A system shell(not shown) that surrounds and is supported by frame 20 includes anaccess door (not shown) at a front of system 10 that can be manuallyand/or automatically operated to access main storage deck 22. However,during normal operations, this access door remains closed.

First preparation deck 24 is located at the front of system 10, andsecond preparation deck 26 is located at the back of system 10. Thesedecks 24 and 26 are positioned parallel to each other and extend alongthe length of system 10. First preparation deck 24 is preferablypositioned lower than second preparation deck 26.

In some embodiments, second deck 26 may be positioned lower than firstdeck 24. This height difference allows a robot to access firstpreparation deck 24 from below. In other embodiments, first and secondpre-analytical processing decks 24, 26 may be located at the sameheight. In such embodiments, a widthwise gap (not shown) may separatefirst and second preparation decks 24, 26 to provide robot accessthereto from below. However, such a gap may increase the front-backwidth of system 10.

Suspended robot deck 28 is located above first and second pre-analyticalprocessing decks 24, 26 so that robots located within deck 28 can reachdownward toward decks 24 and 26. As such, suspended robot deck 28extends along the length of system 10 in correspondence with first andsecond pre-analytical processing decks 24, 26.

Consumable Racks for Use in System

FIGS. 4A-6 depict exemplary embodiments of various sample racks that canbe utilized in system 10 to help accommodate the above mentioned varietyof sample containers. In particular, FIG. 4A depicts a rack 30 adaptedfor holding first-type sample containers 01 and includes a plurality ofuniformly sized receptacles 32 for receipt of containers 01. Rack 30preferably includes thirteen receptacles 32. However, more or lessreceptacles 32 may be utilized. Each receptacle 32 defines discretecylindrical or projecting members 33 a and 33 b. Cylindrical members 33a are located at the corners of rack 30 and each includes an extension38 at a bottom thereof that defines an abutment shoulder. Such shoulderis formed by the smaller dimensions of extension 38 relative tocylindrical member 33 a.

Cylindrical members 33 b are located between cylindrical members 33 a.Members 33 b do not include extension 38. Thus, extensions 38 extendbeyond the length of cylindrical members 33 b such that when rack 30 isplaced on a flat surface, cylindrical members 33 b do not touch the flatsurface so as to form a space between cylindrical members 33 b and thesurface. These extensions 38 are dimensioned to be received within areceptacle 32 of another rack 30 so that multiple racks 30 can bestacked when they are empty. Small indentations (not shown) in the sideof the rack allow the rack to lock into position at different locationsthroughout system 10 to help locate and maintain rack 30 in a specificposition.

Openings 35 extend through the bottom of cylindrical members 33 a-b andcommunicate with receptacles 32. These openings 35 can help with racksanitation and can allow scanners, such as bar code scanners, to scaninformation that may be located on the bottom of a container locatedwithin one of receptacles 32, for example.

As shown in FIG. 4C, an engagement member 39 may be located at a bottomof rack 30. Engagement member 39, as depicted, includes a hollowcylinder 31 that has an opening sized to engage a projection of a rackmover arm (discussed below). Engagement member 39 may be modular so thatit can be attached to rack 30 at a bottom end thereof. For example, inone embodiment a shim portion coupled to hollow cylinder 31 may bepress-fit into spaces between cylindrical members 33 a-b. However, inother embodiments, engagement member 39 may be integrated into thestructure of rack 30 such that hollow cylinder 31 extends from a bottomthereof or is recessed between cylindrical members 33 a-b. When rack 30is placed on a surface, a space is formed between the surface and thebottom of cylindrical members 33 b due to the extended length ofcylindrical members 33 a. The rack mover arm engages engagement member39 which extends from the bottom of the rack 30 but does not interferewith rack stability when the rack 30 is placed on a flat surface.Engagement feature 39 is preferably located at or near a center of massof rack 30 to help stabilize it when it is retrieved by rack mover arm.

Rack 30 also includes at least a pair of peripheral walls 34 located atopposite sides of rack 30. Such walls 34 each include a downward facingsurface 37. Surface 37 is preferably planar and may be utilized byautomated devices for engaging and supporting rack 30.

A handle 36 is located on a single side of rack 30 between andtransverse to the peripheral walls 34. Although a single handle isshown, multiple handles disposed at opposite sides of rack 30 arecontemplated. However, a single handle 36 is preferred in order to keepthe overall dimensions of rack 30 to a minimum for efficient storagewithin system 10. As described below, rack 30 is loaded and retrieved bya user through a single port in system 10. Handle 36, alone, issufficient to load and retrieve rack 30 from the port, particularlysince system 10 delivers rack 30 to the port in the same orientation inwhich it is loaded.

Rack 40, as depicted in FIG. 5, is similar to rack 30 and includes aplurality of receptacles 42. However, receptacles 42 of rack 40 aresmaller than those of rack 30 and are sized to accommodate second-typesample containers 02. Due to the smaller size of receptacles 42, rack 40can include more of such receptacles 42. In a preferred embodiment, rack40 includes twenty receptacles 42. However, more or less receptacles 42are contemplated.

Rack 50, as depicted in FIG. 6, is also similar to racks 30 and 40, butincludes even smaller receptacles 52 that are sized to accommodatethird-type sample containers 03. As such, rack 50 can includesixty-three receptacles. However, again, more or less receptacles 52 arecontemplated.

Racks 30, 40, and 50 have substantially the same peripheral dimensions.In addition, each rack 30, 40, 50 includes a bar code, RFID, or someother identification tag which can be scanned upon entry into system 10,such as automatically by system 10 or manually by the user, in order toidentify the types of containers disposed therein. In addition, racks30, 40, and 50 may be color coded so that a user can easily determinethe type of container that goes into a particular type of rack.

While each rack 30, 40, 50 includes uniformly sized receptacles for asingle size sample container; it is contemplated that a single rack mayinclude receptacles having differing sizes to accommodate various sizesof sample containers. For example, receptacles 32 and 42 can be includedinto a single rack to accommodate both first and second-type samplecontainers 01, 02. It is also contemplated, that receptacles 52, sizedfor a third-type container 03, can be included in a rack along withreceptacles 32 and/or 42. However, it is preferable to separate thethird-type sample containers 03 (or any containers particularly suitedfor an analyzer) into their own rack so that the small containers canbypass sample conversion, as described in more detail below. This helpsenhance speed and reduce complexity of system 10.

FIG. 7 depicts a disposable pipette tip rack 182. Disposable pipette tiprack has the same dimensions as racks, 30, 40, and 50. In addition,disposable pipette tip rack 182 includes a plurality of receptacles 184each sized to receive and suspend a disposable pipette tip so that apipetting robot can retrieve a pipette tip therefrom.

Also, system 10 is adaptable to accommodate other sample racks havingother types of containers. For example, racks similar in structure tothose just described directly above may be particularly adapted toretain blood sample containers/vacutainers.

Main Storage Deck

Referring back to FIGS. 2 and 3, main storage deck 22 includes a rackhandler robot 320 (see FIG. 14) and rack elevator 360 (see FIG. 15)which are primarily disposed within main storage deck 22 and cantraverse main storage deck 22 and into first and secondprocessing/preparation decks 24, 26.

Main storage deck 22 also includes shelving or discrete storage cellsfor holding consumables in an organized fashion. For example, as shownin FIG. 2, main storage deck 22 includes shelving (not shown) for racks30, 40, 50, and 182, shelving (not shown) for a pipette tip wastecontainer 12, and shelving 23 for bulk diluent containers.

Referring to FIG. 2, shelving for various consumables and items arelocated below first and second pre-analytical processing decks 24, 26(FIG. 3). For example, shelving supports consumable racks 30, 40, 50,182 (FIG. 7) and define rack storage positions. Such rack storagepositions can be below both first and second pre-analytical processingdecks 24, 26. In addition, shelving may be provided under firstpre-analytical processing deck 24 which supports bulk diluentcontainers, waste containers for disposable pipette tips, and the likefrom below. Shelving is arranged so as to form a space or runway 25 (seeFIG. 3) extending along the length of system 10 so that robot 320 cantraverse this runway 25 and retrieve racks 30, 40, 50, and 182 fromeither side of runway 25. In this regard, runway 25 extends upward alonga back-end of the sample rack storage positions located at the front ofsystem 10 so that runway 25 intersects a back-edge of first preparationdeck 24. This allows robot 320 traversing runway 25 to retrieve anddeposit racks 30, 40, 50, 182 below first and second preparation decks24, 26 and also above first preparation deck 24.

Shelving 23 for bulk diluent containers 14 or other items may bestatically disposed within storage deck 22 or may be coupled to anaccess door (not shown) so that when the access door is swung open, bulkdiluent containers 14 move with the access door and are presented to auser for easy removal and replacement. Shelving 23 is configured forside-by-side arrangement of the bulk diluent containers 14. However,shelving may also be configured so that the bulk diluent container 14are arranged both side-by-side and vertically.

Storage deck 22 and its configuration is an aspect that allows system 10to perform high-throughput pre-analytical preparation and preprocessingwhile providing long walk-away times for a user by accumulatingsignificant quantities of consumables and allowing for automatedmanipulation thereof when determined by system 10.

Processing Decks

FIG. 7 depicts an exemplary configuration of first and secondpre-analytical processing decks 24, 26. Decks 24 and 26 include numerousdevices and locations for rack/tube placement. As shown, first deck 24includes, from right to left, an angled elevator 100, a first samplerack space 110, an input/output (“I/O”) port 120, a second sample rackspace 112, a sample conversion assembly 130, pipette tip rack space 180with pipette tip rack 182, and a third sample rack space 114/116. Samplerack space 114/116 is the destination location for sample containersthat have been processed through sample preparation/conversion assembly130 First pre-analytical processing 24 deck also includes an opening(not shown) extending therethrough and positioned above pipette tipwaste container 12. Although these devices/spaces are shown disposed onthe first pre-analytical processing deck 24 in a particularconfiguration, it should be understood that each of these device/spacescan be located elsewhere on first pre-analytical processing deck 24without departing from the invention as described herein.

First Pre-Analytical Processing Deck Tube Sealer and First Rack Space

Sample rack spaces 110, 112, and 114/116 can receive any of the sampleracks 30, 40, 50 previously described. However, such spaces 110, 112,114/116 generally receive particular sample racks with a particular loadtherein. Such spaces are designated to receive these particular sampleracks to optimize robotic movements. However, as mentioned such spacescan receive a multitude of different racks. In addition, each samplerack space 110, 112, and 114/116 are generally configured to receive asingle sample rack 30, 40, 50. Although, it should be understood thatsystem 10 can be configured such that rack spaces 110, 112, and 114/116can accommodate more than one sample rack.

In a preferred configuration of system 10, first sample rack space 110receives sample rack 50 with receptacles 52 empty or partially empty.While located within rack space 110, receptacles 52 are loaded withprocessed/used sample containers 03 returned from an analyzer. Elevator100, which is described further below, is placed adjacent to rack space110 and is configured to raise a rack 50 to second deck 26 to be filledwith used sample containers 03 and to lower such rack 50 filled withsuch used containers 03 down to deck 24 at rack space 110 so that rackhandler robot 320 can retrieve the rack 50 from angled elevator 100 andmove it to the storage deck 22.

Input Port & Bar Code Scanner

I/O port 120 is located adjacent to rack space 110. I/O port 120 isgenerally a rectangular enclosure through which sample racks 30, 40, and50 are deposited and retrieved by a user. All sample racks 30, 40, 50and sample containers 01, 02, 03 utilized by system 10 pass through thisport. I/O port 120 may be dimensioned to be slightly larger than asingle rack 30, 40, 50, 182. This helps conserve preparation/processingspace and helps position each rack 30, 40, 50 in substantially the samelocation within I/O port 120 for rack handler robot 320 (describedbelow) to retrieve a rack therefrom. However, it is contemplated thatport 120 may be dimensioned to receive multiple racks placedside-by-side or front-to-back. In addition, a bar code scanner (notshown) is located adjacent to or within I/O port 120 to read bar codeslocated on sample racks 30, 40 and 50 as they are input into system 10.

Sample Preparation/Conversion Instruments

FIGS. 7-8C depict spaces and devices positioned at an opposite side ofI/O port 120 from first rack space 110. Sample conversion (describedbelow) takes place at this side of I/O port 120 and includes samplepreparation/conversion assembly 130, pipette tip rack space 180, andsecond, third, and fourth rack spaces 112, 114/116.

Second sample rack space 112 generally receives either rack 30 or 40which is filled or partially filled with sample containers 01 or 02,respectively, acting as primary sample containers. However, in someembodiments sample rack space 112 can also receive rack 50 includingsample containers 03 that had been previously used by an analyzer. Inother words, rack space 112 can receive sample rack 50 in order to runadditional tests on a sample without removing it from system 10. Thirdsample rack space 114/116 receives sample rack 50 filled or partiallyfilled with empty third-type containers 03, which later act as secondarycontainers for samples contained in containers 01 and 02 or third-typecontainers 03 containing control samples. Also, rack space 180 receivespipette tip rack 182.

Preparation/conversion assembly 130 is preferably located between secondand third rack spaces 112, 114 and generally includes a bar code scanner(not shown), a primary sample container station 140, a secondary samplecontainer station 150, and a diluent dispenser 170. Also one or moreclamp assemblies 160 is optionally provided.

Primary sample container station 140 may include multiple receptacles142 each dimensioned to receive a different size sample container. Forexample, a first receptacle may be dimensioned to receive first-typesample container 01 and a second receptacle may be dimensioned toreceive second-type sample container 02. In some embodiments, a thirdreceptacle for a third-type sample container 03 may be provided, or asingle adjustable receptacle, such as a receptacle with a clampingmechanism, maybe provided to accommodate each sample container type 01,02, and 03. In addition, each receptacle 142 may include engagementfeatures (not shown) located at a bottom thereof for interlocking withcorresponding features located at a bottom of sample containers 01 and02 so as to prohibit sample containers 01 and 02 from rotating therein.Such engagement features allows for a sample container 01, 02 to bede-capped and recapped within a receptacle 142.

Receptacles 142 are also integrated into a motorized base 144. Motorizedbase 144 includes a motor, such as an eccentric motor, which may becoupled, directly or indirectly, to the structure defining eachreceptacle such that station 140 can operate as an agitator or vortexerto re-suspend particulates within a sample. However, in someembodiments, an independent agitator/vortexer may be provided adjacentto station 140.

Secondary sample container station 150 is positioned adjacent primarysample container station 140 and adjacent to diluent dispenser 170.Secondary sample container station 150 preferably has one or more clamps152 to receive third-type sample container 03. Clamps 152 hold thethird-type container 03 so as to prohibit container 03 from rotatingtherein while a cap thereon is decapped and recapped by a decapper robot450, as is described further below. However, in other embodimentspassive receptacles can be provided at station 150 to receive thethird-type sample containers 03. In such embodiments, the receptaclesmay include engagement features that are keyed to a container engagementfeature that may be located on a side of a container 03 or at a collarof container 03. In this regard, the receptacle engagement features maybe correspondingly positioned within receptacles 152 or at top endsthereof. Thus, when a container 03 is disposed in a correspondingreceptacle, the engagement features engage each other to preventrotation of container 03. In either embodiment just described, station150 is configured so that container 03 can be de-capped and recappedwhile remaining in the same location. Similar to station 140, station150 may also be configured with a motorized base 154 to act as anagitator/vortexer for third-type sample containers 03 disposed withinreceptacles 152.

FIGS. 8A and 8B depict an exemplary clamp assembly 160 and diluentdispenser 170 combination. Clamp assembly 160 has moveable jaws that canhold two containers 03 adjacent each other. Such clamp assembly 160 ispositioned adjacent to a track 176 that includes a belt and pulleymechanism. Diluent dispenser 170 is connected to this track 176 and ismoveable along the track 176 so that a multichannel dispense head 172can be positioned over clamp assembly 160 and any containers 03 retainedby such assembly. Diluent dispenser 170 has multiple dispense nozzlesthat are angled inward so that when dispense head 172 is positioned overa container 03, a selected channel 175 can dispense a metered amount ofdiluent into the respective container 03. An ultrasonic sensor 178verifies that dispense occurred by confirming a volume change.

In another embodiment diluent dispenser 170 may include a column risingfrom first preparation deck 24 and a spout or dispense head transverselyextending from column. Dispenser may also include a plurality of diluentchannels. For example, in one embodiment such dispenser may includeeight diluent channels, but may include any number of diluent channels.Channels are isolated from one another such that each channel 175 iscapable of dispensing a different diluent into an empty third-typesample container 03. The diluent that is dispensed depends on thedownstream analysis to be performed on the sample. As such, each channel175 is separately controlled.

As depicted in FIG. 8C, each channel 175 includes first and secondtubing sets 171 and 173 and a pump 176. First tubing set 171 connectsthe pump to the spout 174. The pump 176 may be a dosing pump thatprecisely controls the quantity of diluent dispensed and also includes asensor (not shown) to verify fluid volume. Such sensor can include adistance measuring sensor, gravimetric sensor, optical sensor, and thelike, for example. The second tubing set 173 connects a bulk diluentcontainer 14 to the pump and includes a filter 177. Filter 198 may be a50 u inline filter and is positioned downstream of pump 176 to helpprevent particles, such as coagulated diluent, from getting into pump176. Each channel 175 is connected to a bulk diluent container 14located within main storage deck 22 via a tube cap assembly 178. Capassembly 178 and second tubing set 173 may also have correspondingcomponents of a quick-connect mechanism 179 that allows bulk diluentcontainers 14 to be quickly replaced. The cap assembly 178 and pump 176are arranged beneath deck 24. Additionally, a bar code scanner 199 ispositioned beneath deck 24 and may be configured to concurrently readbarcodes on each of the bulk diluent containers 14 connected to each ofthe plurality of diluent channels 175 so as to feed system 10 withreal-time information regarding available diluents. Alternatively, aplurality of bar code scanners can be positioned adjacent bulk diluentcontainers 14 to perform such function.

Spout 174 acts as a straight-through manifold (schematically illustratedin FIG. 8C) for the plurality of diluent channels 175 and may have afan-shaped opening with each diluent channel 175 terminating at the endof the fan-shaped opening to help prevent cross-contamination as thediluent flows therefrom. In some embodiments, column 172 may be coupledto a stepper motor that rotates column 172 back and forth bypredetermined angular distances so that a designated diluent channel 175aligns with an open third-type sample container 03 located at secondarycontainer station 150. For example, each step of the motor may rotatespout 174 an angle equivalent to an angular distance between adjacentchannels 175. In other embodiments, column 172 may be coupled to alinear actuator that moves dispenser 170 back and forth in a lineardirection to align a diluent channel 175 with a container 03. In furtherembodiments, a receptacle 152 at secondary container station 150 may belinearly translated, such as by moving base 154 via a linear actuator,so that a container 03 disposed therein can be aligned with anappropriate diluent channel 175.

Second Preparation/Processing Deck

Referring again to FIG. 7, second preparation deck 26 includes, fromleft to right, an empty space 200, batch-accumulation area 210, aplurality of bulk vortexers 220, a warmer 230, a shuttle handlingassembly 240, a cooler 290, and a pair of shuttle transport assemblies300 a-b. Second deck 26 also includes a bar code scanner 205 configuredto scan the bar code of a sample container. Although thesedevices/spaces are shown disposed on the second pre-analyticalprocessing 26 deck in a particular configuration, it should beunderstood that each of these device/spaces can be located elsewhere onthe second pre-analytical processing deck 26 without departing from theinvention as described herein.

Rack Elevator Space

As depicted in FIG. 7, empty space 200 is sized to receive sample rack50. Also, as previously mentioned rack elevator 360 (described below) ispartially disposed within storage deck 22 and operates between storagedeck 22 and second pre-analytical processing deck 26. Rack elevator 260is disposed in the back, left corner of system 10 and serves to fillempty space 200 with sample rack 50. Sample rack 50, when occupying thisspace typically includes third-type sample containers 03 which can beeither primary or secondary containers, as is described in more detailbelow.

Batch-Accumulation Area

Batch-accumulation area 210 includes an array of receptacles 212. Forexample, area 210 includes about 200 receptacles but can include more orless. Receptacles 212 are sized to receive third-type sample containers03 and are arranged in a rectangular configuration such that they borderbulk vortexers 220 along two sides thereof. Such shape helps conservespace and minimizes the distance between receptacles 212 and bulkvortexers 220. However, receptacles 212 can be arranged in any geometricconfiguration, such as a rectangular or circular shaped arrangement ofreceptacles 212. Batch-accumulation area 210 receives and accumulatescontainers 03 in batches based on their assay designation. The totalnumber of receptacles 212 for batch accumulation area may vary. However,the total number should be sufficient to maintain sufficient stock ofcontainers 03 to feed analyzers A₁ . . . A_(n) as the analyzers becomeavailable in order to reduce downtime.

Batch-accumulation area 210 is a second accumulation area in addition tostorage deck 22 which is a first accumulation area. These accumulationareas 22, 210 provide system 10 reserves of accumulatedsamples/consumables that can be drawn upon when needed. This allows auser to randomly load and unload system 10 while also allowing completebatches of prepared and preprocessed samples to be distributed to ananalyzer as soon as an analyzer becomes available, thereby minimizingdowntime.

Bar code scanner 205 is arranged adjacent to batch-accumulation area 210and near empty space 200. This allows containers 03 to be scanned byscanner 205 as containers 03 are moved from a rack 50 at space 200 to areceptacle 212.

Bulk Vortexer

As depicted in FIG. 7, second pre-analytical processing deck 26 includestwo or more bulk vortexers 220 (in FIG. 7, four bulk vortexers arearranged in two rows of two) located between batch-accumulation area 210and warmer 230. However, more or less bulk vortexers 220 may be includedand in alternative arrangements. For example, in one embodiment ofsystem 10, two bulk vortexers 220 may be arranged on secondpre-analytical processing deck 26. Each bulk vortexer 220 generallyincludes a body 222, platform 226 and motor 228 (best shown in FIG. 9).Body 222 includes a plurality of receptacles 224 arranged in aquadrilateral array of about thirty receptacles or less. Each receptacle224 is sized to receive a third-type container 03 therein and maycontain an engagement feature (not shown) disposed at a bottom-endthereof for engaging a bottom-end of containers 03 to prevent rotationwithin receptacles 224 during use. Body 222 is arranged on platform 226which is coupled to motor 228, such as an eccentric motor. Motor 228,when turned on, oscillates platform 226 and body 228 to re-suspendparticulates within each sample. Motor 228 is controlled to operate fora predetermined time interval which may be determined by the type ofsamples contained within sample containers 03.

System 10 also includes a vortex controller. When a sample is ready tobe handed off to a vortexer 220, the controller determines if vortexer220 can receive the sample. The programmer/controller also instructsvortexer 220 to operate at a certain speed for a predetermined timeinterval. The vortex controller has a feedback loop that continuouslymonitors vortexer operating conditions and sends an error message if avortexer operating condition fails to match an input instruction. Forexample, if a particular operating speed is instructed, the feedbackloop monitors the actual operating speed. If the operating speed doesnot match the instructed speed, then there is an error which generatesan error message. In addition to generating a first error message, ifthere is an error, the vortexer is reinitialized. If a second errormessage is received then a command for vortexer service/replacement isissued. Thus, auto correction is first attempted, and then a request foruser intervention is sent if the auto correction is not successful. Inall cases a pick and place robot, such as robot 410 a or 410 b, removescontainer 03 from vortexer 220 upon completion.

Warmer

Warmer 230 is disposed between bulk vortexers 220 and shuttle handlingassembly 240, as shown in FIG. 7. Warmer 230 heats samples at aspecified temperature for a specified period of time as determined bythe assay to be performed. For example, in one embodiment, warmer 230heats samples to within about 100° to 115° Celsius for about 9 to 17minutes after equilibration at 100° Celsius.

Warmer 230 generally includes a body 232 comprised of a plurality ofwarming plates 236 made from thermally conductive materials and stackedin a tight arrangement on top of one another. A plurality of receptacles234 extend through warming plates 236 from a top surface of body 232 andare arranged in a quadrilateral array of about 110 receptacles or less.For example, warmer may include 96 receptacles (which can be more orless), which can hold multiple batches of 24 or 32 containers at anygiven time. Heating elements 237 are sandwiched between each plate 236so as to distribute heat evenly throughout body 232. A temperaturesensor 238, such as thermocouple, resistance temperature detector(“RTD”), or thermistor, is located at about mid-height of body 232 andmeasures temperatures therein. Temperature sensor 238 and heatingelements 237 may be coupled to a proportional-integral-derivative(“PID”) controller to help maintain constant set-point temperatures.

Cooler

Cooler 290, as depicted in FIG. 11, generally includes fans 296, one ormore plenum 294, a platform or mounting plate 292 and cooling racks 298.Fan units 296 are positioned directly above second pre-analyticalprocessing deck 26 and are partially surrounded at an upper-end thereofby plenum 294. Platform 292 sits atop of plenum 294 and includesopenings (not shown) that allow air to pass therethrough. Cooling racks298 are positioned over the openings of platform 292. Cooling racks 298can be shuttles 280 or structures integrally formed into platform 292.Cooling racks 298 include a plurality of receptacles 299 sized toreceive third-type containers 03 therein. Openings (not shown) extendthrough a bottom-end of cooling racks 298 and communicate withreceptacles 299. These openings are smaller than receptacles 299 so thatcontainers 03 do not fall therethrough. This arrangement allows air tobe drawn into fans 296 from below and to the sides of fans 296 andexpelled upwardly through plenum 294 and into cooling racks 280 toconvectively cool sample containers 03. This bottom-up cooling approachhelps prevent contaminants from being deposited on the caps ofcontainers 03 and allows for containers 03 to be easily moved in and outof cooling racks 280.

Cooler 290 is disposed at the back, right corner of system 10 andadjacent to shuttle handling assembly 240, as shown in FIG. 7. Cooler290 is generally located at this position so that shuttle handlingassembly 240 acts as a buffer between warmer 230 and cooler 290. Thishelps prevent airflow around cooler 280 from affecting the heatdistribution within warmer 230.

Shuttle Handling Assembly

FIGS. 12A-12C depict a shuttle handling assembly 240. Shuttle handlingassembly 240 generally includes a plurality of shuttles 280, a base 250,a plurality of shuttle docking stations 260 a-c extending from base 250,a drive mechanism 251, a transfer arm assembly 270, and a barcodescanner (not shown). Shuttle handling system 240 is configured to retainsample container shuttles 280 until they are at least partially filledand to transport shuttles 280 to and from a shuttle transport assembly300 (described below).

Shuttle 280, as best shown in FIG. 12B, includes a body 284 and aplurality of receptacles 283 extending into body 284 from a top surfacethereof. The shuttle 280 depicted includes twelve receptacles 283 whichare each sized to receive a third-type sample container 03. However,other embodiments may include more or less receptacles 283 depending onthe capacity of an analyzer coupled to system 10. Additionally,receptacles 283 are arranged in two linear rows 281, 282. Whilereceptacles 283 can be arranged in more than two linear rows, two rowsare preferable.

A plurality of transverse openings 286 extends through body 284 atopposite sides thereof. More particularly, each transverse opening 286intersects a corresponding receptacle 283 such that receptacles 283 infirst row 281 are intersected by transverse openings 286 extendingthrough a first side of body 283, and receptacles 286 in second row 282are intersected by transverse openings 286 extending through a secondside of body 284. These transverse openings 286 are disposed at a lowerend of shuttle 284 and provide access to and communication with a lowerend of containers 03 disposed within receptacles 283.

A plurality of notches 288 extends into a bottom surface of body 284.There are preferably four notches 288 symmetrically distributed aboutbody 284, although more or less notches 284 can be provided. Forexample, three notches 288 may extend into body 284 which may helpensure shuttle 280 is placed in a desired orientation throughout system10. Each notch 284 generally has a semi cylindrical geometry. Thesenotches 284 are configured to engage cylindrical or frustoconicalprojections extending from a surface of the shuttle handling system inorder to retain shuttle 280 on such surface. Although, shuttle 280includes semi cylindrical notches 288 to correspond with cylindrical orfrustoconical projections, any notch geometry matching a surfaceprojection can be selected.

One or more slots (not shown) also extend into the bottom surface ofbody 284 generally near the center of body 284. These slots correspondwith engagement features or flanges (not shown) of transfer arm assembly270 to help transfer arm assembly 270 pickup and hold shuttle 280.

Base 250 is a structural member which supports drive mechanism 251,transfer arm assembly 270, and shuttle docking stations 260 a-c. Drivemechanism 251 operates transfer arm assembly 270 and generally includesa pair of motors 257 a-b and a pair of drive shafts 258 a-b. The firstdrive shaft 258 a is an elongate shaft that has a torque applyinggeometry. For example, first drive shaft 258 a may be a square shaft,hexagonal shaft, or a splined shaft. The second drive shaft 258 b isgenerally an elongate leadscrew. Drive shafts 258 a-b are rotatablyconnected to a pair of end-plates 254 a-b that extend from base 250 at afront-end and back-end thereof. Drive shafts 258 a-b are disposedparallel to each other in a vertical arrangement above base 250 suchthat first drive shaft 258 a is located directly above second driveshaft 258 b. A rail 252 is provided on the top surface of base 250 andis disposed directly below second drive shaft 258 b.

A first and second pulley 255 a-b or sheaves are connected to first endplate 254 a, although they can be connected to second end plate 254 b,and are offset from each other in a front-back direction. First pulley255 a is directly connected to first drive shaft 258 a, and secondpulley 255 b is directly connected to second drive shaft 258 b such thatrotation of these pulleys 255 a-b rotates shafts 258 a-b. First andsecond motors 257 a-b may be rotating stepper motors and are connectedto base 250. First motor 257 a is connected to first pulley 255 a viafirst belt 256 a, and second motor 257 b is connected to second pulley256 b via a second belt 256 b. First and second motors 257 a-b areindependently operable and may have the same or different angle ofrotation per step.

Transfer arm assembly 270, as best shown in FIG. 12C, includes acarriage 271 and transfer arm rotatably connected to carriage 271.Carriage 271 includes a first flange member 272 and a second flangemember 273 extending from a support member 271. Support member 271 isslidingly connected to rail 252. Flange members 272 and 273 are offsetfrom each other to form a gap therebetween. First flange member 272includes first and second openings (not shown). The first opening isconfigured to slidingly receive first drive shaft 258 a while also beingconfigured to allow drive shaft to freely rotate therein such as by acorrespondingly shaped bushing disposed within the first opening. Forexample, where first drive shaft 258 a is a square shaft, the firstopenings may include a rotatable bushing with a square opening, andwhere first drive shaft 258 a is a splined shaft, the first opening mayinclude a rotating bushing having splines configured to engage withdrive shaft 258 a. The second opening of the first flange member 272 isthreaded, such as by a threaded nut being disposed therein andthreadedly engages second drive shaft 258 b such that rotation thereofdrives carriage 271.

Second flange member 273 also includes first and second openings (notshown). These openings may be similar to the first and second openingsof first flange member 272. As such, the first opening of second flangemember 273 receives first drive shaft 258 a such that drive shaft 258 ais slidable and rotatable relative to flange member 273. Also, thesecond opening of second flange member 273 may be threaded to threadedlyreceive second drive shaft 258 b. In some embodiments, second flangemember 273 may not include a second opening and may instead be shaped,such as L-shaped, to be positioned partially about drive shaft 258 b toavoid any engagement thereof.

The transfer arm is comprised of a first arm member 274 and second armmember 276. First arm member 274 is an elongate linkage that includes anopening at a first end thereof. This opening is configured to slidinglyreceive first drive shaft 258 a while also being configured to receivetorque applied therefrom so as to rotate first arm member 274 inconjunction with rotation of drive shaft 258 a. For example, the openingof first arm member 274 may be square shaped, hexagonal shaped, or havesplines configured to engage corresponding geometry of drive shaft 258a. The first end of first arm member 274 is disposed within the gapbetween first and second flange members 272, 273 such that the openingof arm member 274 is coaxial with the first openings of first and secondflange members 272, 273.

Second arm member 276 is rotatably attached to a second end of first armmember 274. Second arm member 276 includes engagement features (notshown) at an end remote from first arm member 274 that are configured toengage slots at a bottom end of shuttle 280.

Belt 278 is engaged with bearing 275 of second flange member 273 betweensecond flange member 273 and first arm member 274. Belt 278 is alsoengaged to second arm member 276 such that rotating bearing 275 in afirst direction rotates second arm member 276 relative to first armmember 274 in the first direction, and rotating bearing 275 in a seconddirection rotates second arm member 276 in the second direction.

Shuttle docking stations 260 a-c, as best shown in FIG. 12A, eachinclude a support wall 262 extending from base 250 and a transversesupport member 264 cantilevered to and extending from support wall 262.Transverse support member 264 includes a plurality of fingers 268 eachpartially defining a space 269 between an adjacent finger 268. Adjacentfingers 268 and a single space 269 define a docking position for singleshuttle 280. Thus, each finger 268 is sized to support two shuttles 280positioned side-by-side. Each space 269 is sufficiently large to receivefirst and second arm members 274, 276 (FIG. 12C) of transfer armassembly 270, yet sufficiently small to prevent shuttle 280 from fallingtherethrough when positioned on adjacent fingers 268.

Each finger 268 includes at least two cylindrical projections 266extending from a top surface thereof. Each projection 266 has a diametersufficiently large to partially fit within adjacent recesses 288 of twoshuttles 280 positioned side-by-side. In other words, a single finger268 supports a portion of two shuttles 280 positioned next to each otherand each projection 266 may be shared by such adjacent shuttles 280.Projections 266 help retain shuttle 280 on a transverse support member264 and help precisely position shuttle 280 for pickup by transfer armassembly 270.

First and second docking stations 260 a and 260 b are positionedopposite of each other such that their respective fingers 268 pointtowards each other. First and second docking stations 260 a-b areseparated by a gap so as to form a runway for transfer arm assembly 270to traverse base 250 in a front-back direction. First and second dockingstations 260 a-b may also include the same number of docking positionsto hold an equal number of shuttles 280. For example, as depicted, firstdocking station 260 a and second docking station 260 b each includeeight docking positions for a total of sixteen docking positions.However, in some embodiments each docking station 260 a-b may includemore or less docking positions and first docking station 260 a mayinclude more or less positions than second docking station 260 b.

Third docking station 260 c is aligned with first docking station 260 aand positioned closer to the front of system 10 than first dockingstation 260 a. Third docking station 260 c generally includes lessfingers 268 and spaces 269, and consequently less docking positions,than first docking station 260 a. First and third docking stations 260a, 260 c are offset from each other by a gap so as to form a transversespace 242 for a first transport assembly 300 a, as described below.Although third docking station 260 c is depicted as being aligned withfirst docking station 260 a, third docking station 260 c can bepositioned in a number of other locations, such as aligned with seconddocking station 260 b. Also, in some embodiments a fourth dockingstation (not shown) can be provided opposite third docking station 260 cand aligned with second docking station 260 b.

The pre-analytical system controller determines the placement of samplesin the shuttle. The shuttles are loaded so that that the shuttles can betransported to any of the analyzers associated with the pre-analyticalsystem. Referring to FIG. 22F, the controller has a shuttle addressassociated with each shuttle receptacle. These “positions” (designatedas 1, 2, . . . n in FIG. 22F), For example, if positive/negativecontrols are loaded on to the shuttle, then the control containers areplaced in locations 1 and 2 in the tray. Note that locations 1 and 2have different positions relative to the shuttle handling assembly 240in that the controls are in the distal positions of the rack relative tothe shuttle robot position for the racks on one side and locations 1 and2 are proximate to the shuttle robot assembly when on the other side.Loading in the manner will allow any shuttle to be transported to anyanalyzer. To enable intelligent loading with knowledge of shuttleorientation the shuttles have a bar code that is read by thepre-analytical system. The pre-analytical system is programmed to knowthe location of the shuttle receptacles from the location of the barcode. As illustrated in FIG. 22F, if the analytical system is to theright of the pre-analytical system, the 1 and 2 positions in the shuttleare in-board (i.e. the first portion of the shuttle to enter theanalyzer). If the analytical system is to the left of the pre-analyticalsystem, then the 1 and 2 positions in the shuttle will be outboard asthe shuttle enters the analyzer.

Referring to FIG. 22D, there is illustrated a shuttle operation forsamples for which tests from more than one analyzer have been ordered bythe workflow computing device 1330 that orchestrates the operation ofthe pre-analytical system 20 and the two or more analyzers. As notedherein the sample when received by the pre-analytical system has aunique identifier label. That unique identifier is referred to as anaccession number herein. The shuttle carries the sample to the firstanalyzer. Workflows for routing samples to a second analyzer

As noted above, when the shuttle returns from the first analyzer, theshuttle is unloaded. In one embodiment, the shuttle is completelyunloaded. In other embodiments, some or all of the sample containers mayremain in the shuttle to be routed to an analyzer for a second test. Theanalyzer for the second test can be the same as or different from theanalyzer that performed the first test. Once emptied, the shuttle isreturned to the parking lot 260 a-c. If there are empty receptacles inthe shuttle for a second assay, the “QUEUE MANAGER” will retrieve othersamples from the batch accumulation area 210 to populate the shuttle forthe designated test. Once the shuttle is loaded with a batch of sampledfor the test, it will then be placed on the shuttle transport assemblyby the shuttle handling assembly 240.

As illustrated in FIG. 7, shuttle handling assembly 240 is generallylocated between warmer 230 and cooler 290. Also, while shuttle handlingassembly 240 is positioned at second deck level and mostly positioned atthe back of system 10, a portion of shuttle handling assembly 240 ispositioned on the same side, or front side, of system 10 as theinstruments of first pre-analytical processing deck 24. Moreparticularly, shuttle handling assembly 240 extends towards the front ofsystem 10 such that third docking station 260 c is positioned adjacentI/O port 120 and first sample rack space 110, while first dockingstation 260 a is positioned adjacent cooler 290 and second dockingstation 260 b is positioned adjacent warmer 230. This allows samplecontainers 03 located at second pre-analytical processing deck 26 to beeasily loaded into shuttles 280 on first and second docking stations 260a-b for distribution to an analyzer, and for shuttles 280 returning froman analyzer to be placed on third docking station 260 c so thatcontainers 03 therein can be easily loaded into rack 50 at space 110.

Shuttle Transport Assembly

FIG. 13 depicts a shuttle transport assembly 300. Shuttle transportassembly 300 generally includes a base frame 302 having a first andsecond transport track 310 a-b. However, in some embodiments shuttletransport assembly may have only one transport track. Transport tracks310 a-b are defined by sidewalls 304 that are slightly wider than awidth of shuttle 280. These sidewalls 304 help prevent shuttle 280 frommoving off of one of tracks 310 a-b as it is being transported. A pairof recesses 306 a and 306 b extends into one end of base frame 302 suchthat each recess extends a short distance along a corresponding track310 a-b. These recesses 306 a-b form a clearance space for transfer armassembly 270 as it rotates downward to deposit shuttle 280 onto one oftracks 310 a-b and rotates upward to retrieve shuttle 280 from one oftracks 310 a-b.

A plurality of pulleys 312 is located on sidewalls that define recesses306 a-b. Such pulleys 312 are each connected to an elongate belt. Forexample, for second track 310 b, a pair of pulleys are connected torespective belts 316 and 317. In this regard, track 310 b includes apair of opposing belts that extend adjacent to and along recess 306 b.This allows a shuttle to be advanced along this section of track 310 bwithout obstructing recess 306 b. Track 310 a is similarly situated.Thus, each track 310 a-b includes at least two belts at an end thereof.This configuration allows belts to reach as close to the recessed end oftransport assembly 300 as possible to help ensure shuttle 380 is placedon belts 313, 314 when deposited thereon by transfer arm 270.

The pair of opposed belts at extend along a portion of their respectivetracks 310 a and 310 b and terminate near an end of recesses 306 a-b.Such opposed pairs of belts then transition to a single belt so that asingle belt 314 extends along the majority of the length of track 310 b,and a single belt 313 extends along a majority of the length of track310 a. Belts 313, 314, 316, and 317 comprise a conveyor and are drivenby one or more motors to move shuttle 280 along each track. In thedepicted embodiment, the conveyors of the first and second transporttracks 310 a-b move in opposite directions. For example, the conveyor ofsecond transport track 310 b is operable to move shuttle 280 away fromshuttle handling assembly 240 and toward an analyzer coupled to system10. Conversely, the conveyor of the first transport track 310 a isoperable to move shuttle 280 away from the analyzer and towards shuttlehandling assembly 240.

Base frame 302 also includes presence sensors 305 at each end thereoffor each track 310 a-b. Thus, each track 310 a-b has a pair of presencesensors 305. These sensors 305 may be optical sensors and can detect thepresence of shuttle 280 when it breaks an optical field. When sensor 305is activated due to the presence of shuttle 280, a signal is sent to acomputing system (described below) thereby notifying system 10 thatshuttle 280 has been transferred to either track 310 a or 310 b. Thecomputing system can then determine next steps, such as whether or notthe conveyor should be turned on or off.

As depicted in FIG. 7, system 10 includes two shuttle transportassemblies 300 a and 300 b which can each feed shuttles 280 to arespective analyzer A₁ . . . A_(n). Although two is depicted, it shouldbe understood that system 10 can be configured to include more shuttletransport assemblies 300 to feed more than two analyzers. First andsecond shuttle transport assemblies 300 a-b are located at about thesame height as second pre-analytical processing deck 26. In addition,first and second shuttle transport assemblies 300 a-b extend along thelength of system 10, are aligned with each other, and are separated by agap 301 (best shown in FIG. 7). This gap 301 allows transfer armassembly 270 of the shuttle transport assembly 240 to position itselfwithin gap 301 in order deposit shuttle 280 onto one of the first orsecond transport assemblies 300 a-b. Additionally, first transportassembly 300 a extends between first and third shuttle holding stations260 a, 260 c such that first and third shuttle holding stations 260 a,260 c are disposed on opposite sides of transport assembly 300 a.

Methods of Shuttle Handling and Transportation

In a method of shuttle handling and transportation, shuttle handlingassembly 240 moves a loaded shuttle 280 to and from one of the shuttletransport assemblies 300 a-b. The shuttle transport assemblies 300 a-btransport the shuttle to and from an analyzer.

In one particular example, an empty shuttle 280 sits on adjacent fingers268 of first shuttle docking station 260 a such that projections 266 arepartially disposed within recesses 288. Each receptacle 280 of shuttle280 has a container 03 disposed therein (particular details of this isdescribed below).

Once shuttle 280 is populated with containers, first motor 257 a isturned on which rotates first pulley 255 a and first shaft 258 a in afirst direction. At this point, transfer arm assembly 270 is generallypositioned in alignment with transverse space 242 (best shown in FIG.12A). As first shaft 258 a rotates, first arm member 274 rotates in thefirst direction toward transverse space 242 while second arm member 276rotates in a second direction away from transverse space 242, whichkeeps engagement features of second arm member 276 pointing generallyupward. First arm member 274 is continuously rotated such that it passesinto transverse space 242 between first transport assembly 300 a andfirst shuttle docking station 260 a (See FIG. 7). First motor 257 a isoperated until first arm member 274 is positioned at about 90 degreesand generally parallel to base 250.

Thereafter, second motor 257 b is turned on and rotates second pulley256 and second shaft 258 b in the first direction, which causes transferarm assembly 270 to be driven toward the back of system 10. Due to firstarm member's generally horizontal position, first and second arm members274, 276 pass under transverse support member 264 of first shuttledocking station 260 a as transfer arm assembly is driven to the back ofsystem 10. Second motor 257 b is stopped when first and second armmembers 274, 276 are aligned with space 269 underneath shuttle 280.

First motor 257 a is then turned on such that first pulley 255 a andfirst drive shaft 258 a are rotated in the second direction. This causesfirst and second arm members 274, 276 to rotate toward shuttle 280.Second arm member 276 remains pointing upward and engages the bottom ofshuttle 280 as first arm member 274 is continuously rotated toward avertical position. Shuttle 280 is then lifted off of first shuttledocking station 260 a while second arm member 276 points upwardlykeeping shuttle 280 upright. Once first arm member 275 reaches avertical position, first motor 257 a stops.

Thereafter, second motor 257 b is turned on such that second pulley 255b and second shaft 258 b rotate in the second direction which drivestransfer arm assembly 270 toward the front of system 10. Due to thefirst arm's generally vertical position, transfer arm assembly 270 movesfreely through the gap between first and second shuttle docking stations260 a-b. Second motor 257 b is operated until transfer arm assembly 270reaches second transport track 310 b of second shuttle transportassembly 300 b and first and second arm members 274, 276 are alignedwith second recess 306 b.

Once transfer arm assembly 270 is in this position, first motor 257 a isturned on such that it rotates first arm member 274 toward second track310 b and rotates second arm member 276 away from second track 310 b sothat shuttle 280 remains upright. First and second arm members 274, 276pass through recess 306 b and one end of shuttle 280 touches down ontoconveyor belts of second track 310 b. As shuttle 280 is touching down,it crosses an optical field of sensor 305, which notifies system 10 ofits presence on second track 310 b. System 10 then determines whether toturn on second track 310 b depending on other circumstances, such asanother shuttle 280 being located at the other end of track 310 b. Onceshuttle 280 touches down, it is disengaged with second arm member 276and is moved toward an analyzer coupled to a left flank of system 10until it reaches an end of second track 310 b where another sensor 305is activated thereby notifying system 10 of the shuttle's location. Atthis point shuttle 280 may be inside the analyzer or near the analyzerdepending on whether or not assembly 300 b extends into the analyzer.

Once analysis of the samples by the analyzer is completed, shuttle 280is placed on first track 310 a activating a sensor 305 located at oneend thereof. This notifies system 10 of the shuttle's presence on firsttrack 310 a where instructions for further operation aredetermined/provided. Shuttle 280 moves toward the recessed end of firsttrack 310 a where shuttle 280 trips the other sensor 305. Belts 313 and314 are turned off such that a portion of the shuttle 280 sits overrecess 306 a.

Transfer arm assembly 270, with first arm member 274 in a generallyhorizontal position, is driven by second drive shaft 258 b intoalignment with first track 310 a such that first and second arm members274, 276 are positioned beneath transport assembly 300 b. First motor257 a is activated and first arm member 274 rotates toward a verticalposition. As this takes place, second arm member 276 passes throughfirst recess 306 a and engages the bottom of shuttle 280 thereby liftingshuttle 280 off of first track 310 a until first arm member 274 isvertical.

Thereafter, second motor 257 b is again activated to drive transportassembly 270 toward the front of system 10 until it is aligned with aspace 269 of third docking station 260 c. First motor 257 a then rotatesfirst and second arm members 274, 276 toward transverse support member264 of the third docking station 260 c which then pass between adjacentfingers 268 and docks shuttle 280 to third docking station 260 c. Whenthe belt is clear, transfer arm assembly 270 may be indexed to return toa position aligned with transverse space 242.

This method is one example of the shuttle's movement to and from ananalyzer using transfer arm assembly 270 and transport assembly 300 b.It should be understood that transfer arm assembly 270 can move ashuttle 280 in any sequence between first, second and third dockingstations 260 a-c and first and second transport assemblies 300 a-b byintermittently rotating first and second arm members 274, 276 throughvarious angles within a 180 degree arc and driving carriage 271 forwardand backward along base 250.

Shuttle Transport Monitoring and Error Protocols

System 10 has a shuttle processor that controls operation of a shuttleprocessing or transport module/subsystem 750 (see FIG. 19A), which mayinclude shuttle handling assembly 240 and shuttle transport assemblies300 a-b. Such processor may be associated with the one or moreprocessors 804 of the computer control device 802 of system 10 describedin more detail below. The shuttle processor has processing logic thatidentifies processing errors, sends notices to the operator and shutsdown the subsystem in response to certain detected processing errors.For example, handling assembly 240, transport assembly 300 a and/ortransport assembly 300 b may be shut down. However, in response tocertain conditions, subsystem operation continues but with adjustments(retries, operating at half speed, etc.) to avoid shutting down inresponse to every detected error. In response to certain detectedconditions, the subsystem executes preprogrammed routines to determinethe source of the error (i.e., a broken sensor, a shuttle 280 in thewrong location, etc.). For example, the shuttle processor has aninitialization protocol to ensure that the shuttle transport assemblies300 a-b are operating correctly on start up. Motion failure indicationsallow for one retry before an error message is issued in response towhich the shuttle processor enters a failed state and a service callissues. The shuttle belts 313, 314 are initialized periodically duringoperation to ensure that they are operating correctly. Again, whenmotion failures are detected there is retry before a failure isindicated, which is reported by the system 10 to an operator.

The shuttle processor also monitors and coordinates the operation of theshuttle transport assemblies 300 a-b with respective analyzers. When ashuttle transport assembly 300 a-b receives a request that an analyzeris ready for a batch of preprocessed samples, a shuttle 280 is retrievedand placed on the belt of either assembly 300 a or 300 b that willtransport the shuttle to the designated analyzer module (A₁, A₂, orA_(n)). System 10 ensures that the belt is clear before proceeding totransfer a shuttle 280 to the selected shuttle transport assembly andthat the respective analyzer is ready to receive the samples. If not,system 10 waits until the prior batch is cleared.

Furthermore, movement of the shuttle handling assembly 240 is monitoredto ensure compliant operation. When motion errors or encoder countmismatches, such as encoder counts of motors 257 a-b, are detected formovement of transfer arm assembly 270, a retry is permitted at reducedspeed after which, if errors in movement or response are detected andend module operation error issues, the operator is notified. A shuttlebarcode reader (not shown) is proved at assembly 240 to not only verifythat the correct shuttle 280 is transported, but to ensure that theassembly 240 itself is operating properly. If a barcode is still notread after one retry, the shuttle 280 is moved to a position todetermine if the error is the barcode or an absence of a shuttle 280. Ifthe barcode is read but it is not the expected bar code, the shuttle 280is transported to the shuttle unloading area 260 c where its contentsare placed in an output rack disposed at rack space 110.

Similarly, sensors provide information to the shuttle processor of thehandoff of the shuttle 240 from the analyzer to system 10. Therespective belts 313, 314 of assemblies 300 a-b are monitored forcorrect operation. If belt errors are detected, the handoff operation isended and a service call is indicated. When motion errors are detectedat the transition from the analyzer to the pre-analytical system 10, oneretry at reduced belt speed is permitted before handoff operation ishalted and notification of an error is sent to the operator. Sensors areprovided at the interface between the analyzer (A₁, A₂, A_(n)) and thepre-analytical system 10 to detect shuttle passage from one to theother.

The analyzer provides a hand off message to the pre-analytical system 10when a shuttle 280 is returned from the analyzer to the pre-analyticalsystem 10. If there is no handoff message, this indicates a problem withthe analyzer. Consequently, all remaining shuttles 280 (if any)associated with the batch of samples being processed by the analyzer aresent to the output rack 260 c where the samples are unloaded into a rack50 at space 110 and designated “unprocessed.” If a handoff message isreceived from the analyzer, the return belt of one of assemblies 300 a-bfrom the analyzer back to the pre-analytical system 10 is turned on.Sensors communicate belt operation and, if a motion error is detected,the belt 113, 114 is paused and an error message sent.

Sensors also indicate if a shuttle 280 is present at the interfacebetween the analyzer and the pre-analytical system 10. If the analyzersent a hand off message and the pre-analytical system 10 is ready toreceive a shuttle 280, then the belt 113, 114 is started. If no shuttleis received, then handoff is stopped and a notice is sent to theoperator that service is required. If a shuttle 280 is detected at theinterface then the shuttle processor sends a signal to the analyzer (A₁,A₂, A_(n)) that hand off is complete. If such a message is received thenthe process is completed. If no message is received, this indicates anerror such as a stuck shuttle, a sensor problem, etc. and the operatoris notified.

Certain errors may have specific protocols that may differ from othererrors. For example, if a pipette tip used by an analyzer is stuck in asample container within a shuttle 280, the analytical module (A₁, A₂,A_(n)) flags the shuttle as having a stuck tip. Logic is provided byshuttle processor that causes such a shuttle 280 to be conveyed to aholding area, such as docking station 260 c. In addition, the operatoris notified that the shuttle requires special processing. If the holdingarea is full, then the pre-analytical system 10 will not receive anymore shuttles until the holding area is emptied.

Once the shuttle 280 has been conveyed to the spot where it will beunloaded, a message is sent to the analytical module (A₁, A₂, A_(n))acknowledging receipt of the shuttle 280. If the shuttle 280 is notdetected in the unloading spot 260 c, placement is retried, verifyingpresence of the shuttle 280 via the barcode reader. If shuttle 280 isstill not detected then the system 10 issues an error that the unloadsensor is broken. The shuttle processor then instructs the pick andplace robot 410 a to unload the third type sample containers 03 from theshuttle 280 (one by one) and place the third type x containers 03 in therack 50 at space 110.

The system 10 monitors for errors in processing when an analyzer (A₁,A₂, A_(n)) sends an indication to the pre-analytical module 10 that itis ready to receive a batch of samples. In response, the pre-analyticalsystem 10 (i.e. the processor) sends the relevant shuttle 280. In theevent of a system disruption (e.g. manual operator intervention), thesystem 10 verifies that the correct shuttle 280 is sent by reading thebar codes on the shuttles 280 loaded with samples and parked awaitingprocessing. The location of each shuttle 280 is stored in a memory, suchas memory 804 described below, and a command is sent to the shuttlehandler 240 to retrieve the relevant shuttle 280 from its known locationand place it on the appropriate shuttle transport assembly 300 a-b.

The pre-analytical system 10 already has stored in memory an associationbetween a particular shuttle 280 and its “parking spot.” If there is adetected mismatch, the shuttle 280 is lifted from its current positionand moved to a test position and evaluated to determine if there is anactual error or a sensor error. If a sensor error has occurred, then thepre-analytical system 10 puts the shuttle 280 in an empty location, suchas on one of docking station 260 a-c, and proceeds with processing. If ashuttle 280 is determined to be present when it should not be, ordetermined not to be present when it should be, there is a system errorregistered and shuttle transport is halted.

If the system 10 determines that the inventory of shuttles 280 matchesthe inventory sensor readings, a routine is entered to determine if thetransfer arm assembly 270 of the shuttle handling assembly 240 is on thecorrect side. In other words, the routine determines if transfer armassembly 270 is in a position to retrieve a shuttle 280 from thedesignated docking station 260 a-c. For example, if assembly 270 isrotated so that it is positioned underneath docking station 260 b,assembly 270 is not in a correct position to retrieve a shuttle 280 fromdocking station 260 a. A routine is provided to move the assembly 270 tothe correct side as needed. If a motion error is detected, the logicallows for a retry at reduced speed before an error message is sent.

The movement of the transfer arm assembly 270 continues to be monitoredas it positions to pick up shuttle 280, picks up shuttle 280, movesshuttle 280 to a bar code reader and places shuttle 280 on the transportassembly 300 a or 300 b to be sent to an analyzer (A1, A2, An). Ifmotion errors are detected, the motion is tried at reduced speed. If themotion error occurs again, the run is ended and the operator is notifiedof the error. If the barcode reader cannot read the bar code of theshuttle or reads a code that it does not expect, then the code is readagain. If the error persists then the system 10 will determine that theshuttle 280 that was obtained was not the correct shuttle. The operatorwill be notified that intervention is needed.

When the shuttle 280 is placed on the belt, sensors detect its presence.If the sensor does detect a shuttle 280, the transfer assembly conveysthe shuttle 280 to the analytical module. Sensors are also provided onthe transfer assemblies 300 a and 300 b to monitor the progress of theshuttle 280 toward the designated analyzer. If the sensors determinethat the shuttle 280 has not been conveyed to the analyzer, there is aretry at reduced speed before the system 10 transmits a message forcustomer intervention.

System 10 is also capable of automatically managing shuttle transportupon reboot in the event of a power loss. In one embodiment, thepre-analytical system 10 has sensors and logic that perform a sequenceof functions for shuttle power recovery prior to returning to normaloperations involving: i) I/O and post analysis module 710 (describedfurther below); ii) shuttle transport assemblies 300 a-b; iii) shuttlehandling assembly 240; iv) shuttle docking stations 260 a-b; and v) ashuttle penalty box. Examples of routines that are initiated by thepre-analytical system 10 in the event of a power loss are as follows.Generally these routines, along with sensors and the last known state ofsystem 10 recalled from a memory thereof are used to return the system10, including subsystem 750, to a ready state following an unexpectedpower loss.

Regarding I/O and post analysis module 710, a flag is set for normalprocessing until all shuttles 280 are emptied and the sample tubescontained therein at shutdown are disposed in an output rack 50 atstation 110. Holding positions at station 260 c are also sensed for thepresence of a shuttle 280. If a shuttle is in a holding position, theshuttle is retrieved by arm 270, its barcode is read and the shuttle 280is returned to docking station 260 c.

Regarding the shuttle transport assemblies 300 a-b, the sensors thereofare scanned for indications that a shuttle 280 is located on its belt.If no shuttle 280 is detected, the transport belts 113, 114 are run. Ifan inboard sensor (i.e., a sensor nearest to assembly 240) is triggered,then a shuttle 280 is detected. If the sensors indicate a shuttle 280 ispresent at the pick-up/drop off shuttle location adjacent gap 242, thenthe shuttle barcode is read and the shuttle 280 is placed in queue forunloading of its sample containers to a rack 50 at location 110. If ashuttle 280 is detected at the delivery/return position adjacent ananalyzer, the tracks 113, 114 are run and, if the inboard sensor istriggered then the shuttle is associated with a barcode and placed inqueue for unloading. If the inboard sensor is not triggered by a shuttle280, then a sensor or track error is indicated.

The shuttle processor resets the shuttle handling assembly 240. Armassembly 270 of the shuttle handling robot 240 is placed in its homeposition. If arm 270 is in an upright position, and the arm 270 may havea shuttle 280 connected thereto that needs to be cleared. In thisregard, the arm assembly 270 along with shuttle 280 is then moved to thebarcode reader so that the shuttle bar code can be read. Thereafter, theshuttle 280 is then placed on a shuttle transport assembly 300 a-b (ifavailable). However, if the barcode cannot be read then shuttleinventory is updated. The shuttle handling assembly 240 is thenavailable.

Regarding docking stations 260 a-b, such docking stations 260 a-b arecleared using the shuttle handling assembly 240 to lift a shuttle 280from the lot, present it to the barcode reader and return the shuttle toits respective docking station after the barcode is read and theinventory is updated. If no barcode is read, the system 10 has a sensorthat determines if there was a shuttle present or not. If a shuttle 280is present, it is placed back in the space from which it was retrievedand the system brings the problem to the operator's attention. If thereis no shuttle 280, then the parking spot is marked empty in inventory.In either event, the inventory is updated with the information.

Before start up, all shuttles 280 are moved from the tracks 300 a-b toeither the unload position or the parking lot 260 a-c as appropriate.

A shuttle penalty box has a sensor that initiates a process fordetermining how to instruct an operator about the shuttle 280 in thepenalty box. If a shuttle 280 is detected, a message is sent to theoperator and the system 10 enters pause. The operator can then open thesystem 10 and remove the shuttle 280, or hand scan the sample containersin the shuttle 280, after which the operator indicates that the shuttle280 has been removed/replaced. If a shuttle 280 is not detected, theoperator is again messaged to address and retry to return the shuttle280. If no shuttle 280 is detected, the system 10 is shut down, theoperator is notified and the error is reported. If the shuttle 280 hasbeen fixed or replaced, the doors of system 10 will close and the system10 will resume operation. If the doors fail to close, system 10operation ceases and a door sensor failure is reported to the operator.If the doors are closed, the shuttle handling system 240 will barcodescan the sample containers and move it to the unload position, where thecontainers will be unloaded and barcoded.

It should be understood that the sensors described above with respect tothe described shuttle transport error protocols and power loss protocolscan include sensors that are well understood in the art. For example,optical sensors can be used to determine the presence or non-presence ofa shuttle, and motor encoders can be used to determine belt positions ofassemblies 300 a-b and transport arm assembly 270 of rack handlingassembly 240.

Shuttle Clamp

As shown in FIG. 12D, docking station 260 c may optionally include ashuttle clamp mechanism 241. This mechanism 241 may be utilized to helprestrain a shuttle 280 docked at station 260 c so that shuttle 280 isnot incidentally lifted off of its parking spot while individual, usedcontainers 03 are being removed from it. Clamp mechanism is not poweredby a power source and includes a clamp arm 245, an actuating arm 246, abase 248, and a torsional spring. The clamp arm 245 includes aprojection 244 which, when in the clamped position, engages a side slot286 of a shuttle 280. Clamp arm 245 is connected to the torsion spring247 and is biased in a clamped position via engagement between a lever249 that projects from clamp arm 245 and torsion spring 247, as shown.Clamp arm 245 may be locked in an un-clamped position, not shown, via aclutch within base 248. Movement of clamp arm 245 between the clampedand unclamped position is achieved via engagement between actuating arm246 and a paddle 279 that extends from arm assembly 270. Thus, when armassembly 270 moves in a front direction past actuating arm 246, it movesactuating arm 246 to an unclamped position. In this regard, arm assembly270 can deposit or remove a shuttle 280 at docking station 260 c. Whenarm assembly 270 moves in a back direction, paddle 279 trips theactuating arm 246 releasing the clutch and allowing clamp assembly 241to engage a shuttle 280 if present at docking station 260 c.

Angled Elevator

FIG. 12E depicts an angled elevator 100. Angled elevator raises andlowers a rack 50 between decks 24 and 26. Thus, when containers 03 areoffloaded from a shuttle 280 at station 260 c, the containers 03 areloaded onto a rack 50 held by elevator 100. In this regard, elevator 100includes a rack holding structure 102 which is connected to an elongatemember 104 that extends along an oblique axis. The rack holdingstructure 102 moves along the elongate member 104 between station 110 atdeck 24 and a position adjacent station 260 c.

Interdeck Robots

FIGS. 14 and 15 depict a rack handler robot 320 and a rack elevator 360,respectively. Rack handler robot 320, rack elevator 360, and angled rackelevator 100 (described above) comprise inter-deck robots or a rackelevator robot system. Such rack elevator robot system can transportracks 30, 40, and 50 between decks 22, 24, and 26. For example, rackhandler robot 320 moves racks 30, 40, and 50 between storage deck 22 andfirst pre-analytical processing deck 24. In addition, rack elevator 360transports rack 50 between storage deck 22 and second pre-analyticalprocessing deck 26, and angled rack elevator 100 transports racks 50between deck 24 and deck 26. However, it should be understood that in apre-analytical system where decks 24 and 26 are not located at differentvertical heights, the rack elevator robot system may only include rackhandler robot 320. In other words, the vertical height differencebetween decks 24 and 26 helps minimize the front-back width of system 10as system 10 is stretched vertically. Thus, elevators 100 and 360 helpaccount for this vertical elevational difference. However, system 10 canbe configured such that decks 24 and 26 are at the same height and areprovided with a horizontal gap between them that allows for robot 320 toreach both decks.

Rack Handler Robot

Rack handler robot 320 generally includes a horizontal track member 330,vertical track member 340, and rack carriage 350. Horizontal trackmember 330 includes an elongate base 332 and one or more rails 334extending from a surface of base 332 along a length thereof. Verticaltrack member 340 similarly includes an elongate base 342 and one or morerails 344 extending from a surface of base 342 along a length thereof.Vertical track member 340 is slidingly connected to rails 334 ofhorizontal track member 330 via a horizontal rail mount 345 that isconnected to and extends from a bottom of vertical member 340. Verticaltrack member 340 is connected to horizontal mil mount 345 in this way sothat vertical member 340 extends vertically and generally orthogonallyrelative to horizontal member 330 and such that vertical member 340 canslide in a left-right direction along horizontal member 330.

Vertical track member 340 is magnetically driven along horizontal member330 via a linear motor, such as by a Festo Linear Motor Actuator(“FLMA”) (Festo AG & Co. KG Esslingen Neckar, Germany), for example. Acable sleeve 339 may be provided adjacent to horizontal member 330 forelectrical cables in order to protect the cables and keep them in placeas vertical track member 340 is moved. In an alternative embodiment,pulleys or sheaves are attached to base 332 of horizontal member 330 andto horizontal rail mount 345 and are used in conjunction with a belt tomove vertical track member in a right-left direction.

Rack carriage 350 includes a base 351, a vertical rail mount 352, firstand second rack support members 354 a-b, and a rack mover arm 322.Carriage 350 is generally disposed directly above horizontal rail mount345 and is moveable relative thereto via vertical rail mount 352.Vertical rail mount 352 is slidingly connected to rails 344 of verticalmember 340 and base 351 is cantilevered to vertical rail mount 352.

First and second rack support members 354 a-b are elongate beams thatinclude planar, upward facing surfaces 357 that are configured to engagedownward facing surfaces 37, 47, and 57 of racks 30, 40 and 50. Racksupport members 354 a-b are substantially parallel to each other andeach have substantially the same length “L” (best shown in FIG. 14E). Inthis regard, first rack support member 354 a is connected to base 351and second rack support member is connected to vertical rail mount 352such that first and second rack support members 354 a-b are spaced adistance substantially equal to a distance between opposing peripheralwalls 34, 44, and 54 of racks 30, 40, and 50, respectively (bestillustrated in FIG. 14B). This provides a gap for a portion of racks 30,40, 50 to fit therein and for rack support members 354 a-b to engage andsupport racks 30, 40, 50 via their peripheral walls. In addition, thisgap between first and second rack support members 354 a-b opens in afront-back direction. The front-back length of the gap is delimited bythe length “L” of rack support members 354 a-b.

As best shown in FIGS. 14B-14F, a rack mover arm 322 is disposed withinthe gap between rack support members 354 a-b and is connected to a motor356 attached to base 351. Motor 356 is operable to extend rack mover arm322 outwardly in one of two directions which are transverse to thelength of horizontal track member 330. In the depicted embodiment, rackmover arm 322 includes first and second elongate members 326, 328. Firstelongate member 326 is connected to a rotating coupling 324 disposed onbase 351. The rack mover arm 322 is positioned between support members354 a-b. Second elongate member 328 is rotatably connected to an end offirst elongate member 326 remote from rotating coupling 324 which formsan elbow 327. Second elongate member 328 includes an engagement featureor a projection 329 at an end thereof remote from first elongate member326. Engagement feature 329 projects upwardly and is configured toengage engagement member 39 of rack 30 and also the engagement membersof racks 40 and 50 so that rack mover arm 322 can pull a rack onto racksupport members 357 a-b and push a rack of off rack support members 357a-b.

In this regard, a pulley 325 is fixedly attached to second arm 328 androtatably attached to first elongate arm 326 at elbow 327. A belt 323 isconnected to pulley 325 and rotating coupling 324 such that rotation ofrotating coupling 324 via operation of motor 356 causes second elongatemember 328 to rotate relative to first elongate member 326. Thisconfiguration allows rack mover arm 322 to move a rack 30, 40, 50 fromone side of horizontal track member 330 to the other as best illustratedin FIGS. 14E and 14F. As such, rack mover arm 322 has at least threedifferent positions: a front position, a back position, and anintermediate position.

In the intermediate position, first and second elongate members 326, 328are generally aligned perpendicular to the length “L” of rack supportmembers 354 a-b and engagement feature 329 is situated within the gapbetween rack support members 354 a-b. In this position, elbow 327 mayproject beyond support member 354 a in a left-right direction (see FIG.14F as an example). In the particular embodiment depicted, elbowprojects into a covered space within vertical track member 340. Rackmover arm 322 generally assumes the intermediate position when a rack islocated on rack support members 354 a-b and/or to traverse runway 25.

In the back position (best shown in FIG. 14E), second elongate member328 is obliquely angled relative to first elongate member 328 andengagement feature 329 is positioned outside of the gap beyond thelength “L” of rack support members 354 a-b in the front-back direction.It is noted that elongate members 326 and 328 are configured so thatwhen rack mover arm 322 is moved from the intermediate position to theback position, engagement feature 329 moves in a linear directionparallel to rack support members 354 a-b and remains situated betweenrack support members 354 a-b as it is advanced through the gap. Thefront position is similar to the back position with the difference beingthat engagement feature 329 is positioned at an opposite end of racksupport members 354 a-b than when rack mover arm 322 is in the backposition. Rack mover arm 322 generally assumes one of these positionswhen transferring a rack off of rack support members 354 a-b or moving arack onto rack support members 354 a-b.

As mentioned above, vertical mount 352 is connected to vertical trackmember 340. A plurality of pulleys 349 or sheaves are connected to oneor more side surfaces of horizontal member 342 and to vertical mount352. These pulleys 349 are connected via one or more belts 347. A motor348 is attached to vertical member 340, which drives belt 347 andpulleys 349 allowing for vertical mount 352 to be driven along rails 344of vertical track member 340 in two linear directions (i.e., up anddown). This allows carriage 350 to be moved vertically. A cable sleeve341 may be provided adjacent to vertical track member 340 for electricalcables that feed motor 348 in order to protect the cables and keep themin place as carriage 350 is moved.

Rack handler robot 320 is positioned within runway 25 located withinstorage deck 22 such that horizontal track member 330 extends along thelength of system 10 in a left-right direction. In addition, verticalmember 340 extends upwardly beneath first and second rack transportassemblies 300 a-b so that an end of vertical track member 340 remotefrom horizontal track member 330 extends above first pre-analyticalprocessing deck 24. The height difference between first and secondpre-analytical processing decks 24, 26 allows carriage 350 to reachfirst pre-analytical processing deck 24 to retrieve racks 30, 40, 50therefrom and place racks thereon 30, 40, 50. Thus, as described,carriage 350 can move in a left-right direction through storage deck 22,in an up-down direction between storage deck 22 and first pre-analyticalprocessing deck 24, and can reach out to retrieve or place a rack 30,40, 50 in a front-back direction.

Rack Elevator

Rack elevator 360, as shown in FIG. 15, generally includes a guidemember 365, carriage 361, and carriage drive mechanism 370. Guide member365 includes a base 366 and at least one rail 367 (two are illustrated)extending along a surface of base 366.

Carriage 361 includes three support members (only first support andthird members are shown) connected together in the shape of a “U”. Thefirst and third support members 362 a, 362 c are disposed opposite eachother and extend in generally the same direction. First and thirdsupport members 362 a, 362 c are spaced a distance substantially equalto a distance between opposing peripheral walls 54 of rack 50. Thisprovides a gap for a portion of racks 50 to fit therein and for supportmembers 362 a, 362 c to engage and support rack 50 via their peripheralwalls (best shown in FIG. 15). Third support member 362 c is slidinglyattached to rails 367 of guide member. The second support memberprovides a backstop for a rack 50 disposed between first and thirdsupport members 362 a, 362 c.

Drive mechanism 370 includes a motor 372 and drive shaft 374. Motor 372is attached to a lower end of base 366 via a bracket 376. Drive shaft374 is connected to motor 372 and to third support member 362 c at anend of drive shaft 374 remote from motor 372. Motor 372 may be a linearmagnetic motor configured to manipulate drive shaft 374 in an up-downdirection. Alternatively, motor 372 may be a rotating stepper motor anddrive shaft 374 may be threaded and threadedly engaged to third supportmember 362 c. Such stepper motor may be configured to rotate in oppositedirections which would rotate drive shaft 374 in opposite direction todrive carriage 361 in an up-down direction along rails 367.

As mentioned above, rack elevator 360 is positioned in the back, leftcorner of system 10 and is partially disposed within storage deck 22beneath second pre-analytical processing deck 26 and partially disposedwithin space 200 so that elevator 360 can position a rack 50 withinspace 200 from below.

Methods of Rack Handling and Transportation

In a method of rack handling and transportation, rack handler robot 320moves a rack 30, 40, or 50 between a designated rack storage positionwithin rack storage deck 22 and first pre-analytical processing deck 24.Rack handler robot 320 also moves a rack 50 among first pre-analyticalprocessing deck 24, storage deck 22 and rack elevator 360. Rack elevator360 moves a rack 50, once received from rack handler robot 320, betweenstorage deck 22 and second pre-analytical processing deck 26.

In one particular exemplary method, a rack 30 is placed into I/O port120 by a user. Motor 346 is turned on which operates pulleys 336 andbelt 338 to drive carriage 350 and vertical member 340 along rails 334in a direction toward I/O port 120. When carriage 350 is aligned withI/O port 120 in a front-back direction, motor 346 is turned off.

Motor 348 is turned on which operates pulleys 349 and belt 347 to movevertical rail mount 352 upward from storage deck 22 toward firstpre-analytical processing deck 24. Motor 348 can be operatedconcurrently with motor 346, such as while carriage 350 and verticalmember 340 are moving in a left-right direction, or sequentially, suchas once carriage 350 and vertical track member 340 have stopped.

Once rack support members 354 a-b reach a position in which they arealigned with peripheral walls 34 of rack 30 and slightly below downwardfacing surfaces 37, motor 348 is stopped. At this point, support members354 a-b are separated from rack 30 by a distance which is overcome byoperating motor 356. This moves rack mover arm 322 across such distancein a forward direction toward rack 30 and into the front position inwhich engagement feature 329 is positioned slightly below engagementmember 39 (best shown in FIG. 14D). Mover arm 322 then engages rack 30via the moveable arm's engagement feature 329. This may be achieved bymoving carriage 350 slightly upwardly so that engagement feature 329catches engagement member 39. Motor 356 is then operated in an oppositedirection into the intermediate position such that moveable arm 322moves in a backward direction to pull rack 30 onto support members 354a-b such that downward facing surfaces 37 rest on upward facing surfaces357. Once fully positioned thereon, motor 356 stops.

Motor 346 is then turned on such that carriage 350, rack 30, andvertical member 340 move in a left-right direction toward a rack storageposition within storage deck 22. When rack 30 is aligned with adesignated rack storage position, motor 346 is turned off. Motor 348 isturned on, either concurrently or sequentially to motor 346, to movecarriage along rails 344 and to move rack 30 downward toward a rackstorage position within deck 22. Motor 356 then operates to move rackmover arm 322 outwardly either forward or backward into the front orback position, depending on the location of the rack storage position,which slides rack 30 off of support members 354 a and 354 b and into thedesignated rack storage position.

In another exemplary method of rack handling and transportation, rackhandler robot 320 repeats the above described process of concurrent orsequential motor operation to move carriage 350 up to firstpre-analytical processing deck 24 in alignment with a rack 50 positionedat third sample rack space 114. Rack mover arm 322 is extended in aforward direction into the front position and toward third sample rackspace 114 and engages rack 50. Moveable arm 322 is then operated to pullsample rack 50 in a backward direction and places rack 50 onto supportmembers 354 a-b.

Carriage 350 is then moved toward rack elevator 360 (FIG. 15) such thatsupport members 354 a-b of rack handler 320 align with support members362 a, 362 c of rack elevator 360. Rack mover arm 322 is then moved fromthe intermediate position to the back position such that moveable armslides rack 50 off of carriage 350 in a backward direction and ontocarriage 361 until rack 50 abuts the backstop provided by the secondsupport member of carriage 361. In other words, rack mover arm 322hands-off rack 50 to rack elevator 360.

Thereafter, motor 372 of rack elevator 360 is operated to drive carriage361 along rails 367 in an upward direction to fill space 200. Samplecontainers 03 located with rack 50 are unloaded and motor 372 isoperated in a reverse direction to lower rack 50. Rack handler 320 againaligned with rack elevator 360 and retrieves rack 50 from therefrom.Rack handler 320 then transports rack 50 to a rack storage positionwithin storage deck 22 or up to first pre-analytical processing deck 24where it is removed from carriage 350.

The sequence of motor operation is implemented by a computing systemwhich is described below. Although it is contemplated that rack handlerrobot 320 could perform the functions of rack elevator 360 (i.e., insertrack 50 into space 200 at second pre-analytical processing deck 26) suchrobots are complementary in that rack elevator 360 frees-up rack handlerrobot 320 to perform the above described functions while samplecontainers 03 are being removed from rack 50.

In addition, the methods described immediately above with regard to rackhandler 320 and rack elevator 360 are examples illustrating the movementof and interplay between rack handler robot 320 and rack elevator 360.In this regard, it should be understood that rack handler robot 320 canmove racks 30, 40, and 50 to and from any location within storage deck22 and first pre-analytical processing deck 24.

Rack Transport Monitoring and Error Protocols

System 10 has a rack processor that controls operation of rack handlerrobot 320 and rack elevator 360. Such processor may be associated withthe one or more processors 804 of the computer control device 802 ofsystem 10 described in more detail below. In one embodiment, operationallogic is provided via processor for the control of the rack handlerrobot 320 so that that system 10 “knows” when a rack, such as rack 30,40, and 50, has been successfully transferred to and from the rackhandler robot 320. For example, there is a feedback loop provided sothat, after an instruction has been issued to the robot 320 to transfera rack from either the main storage deck 22 or the rack elevator 360 tothe robot 320, the system 10 will know whether or not the transfer hasbeen successful. In this embodiment, the robot 320 is provided withsensors that signal whether or not the rack mover arm 322 of the robot320 is in the front, back or intermediate positions. The robot 320 isalso provided with fore and aft sensor that can sense where a rack ispositioned on the rack carriage 350. Such sensors can be optical sensorsor any other sensor known in the art. With these sensors, the followingcombinations of signals suggest the following actions:

Arm Home Sensors (In, Motion Out, NA) In In In In Error In In In ForeFD-11 Y N Y N any N Y N sensor (Y, N) Aft FD- Y N N Y any N N N 11sensor (Y, N) Relevant N Y Y Y any N N N Mailbox Inventory FD11 (Y, N)Status Rack Rack still Rack Rack Arm Fore Aft Not successfully in rackonly only part stuck FD11 FD11 determined moved onto storage partiallyway part way sensor sensor robot location moved moved if failure failureonto being robot (if moved rack from the being back of moved the robotfrom to the front to front of back on the robot robot) for transferAction OK Message Service Service Service Service Service Service touser to Call, if Call, if Call Call Call Call check moving moving rackand reinsert; after retry limit call service

The following conditions after the command to move the rack from therack handler robot 320 into the rack storage area 22 or the elevator 360indicates the following actions.

Arm Home Out to Out to Out to Out to Out to Out to Out to In; SensorsEncoder Encoder Encoder Encoder Motion Encoder Encoder Encoder Motion(In, Out, NA) Count Count Count Count Error Count Count Count Error ForeFD-11 N Y Y N any N Y N Y sensor (Y, N) Aft FD-11 N Y N Y any Y N N Ysensor (Y, N) Relevant Y N Y Y any Y Y N N Mailbox Inventory FD11 (Y, N)Status Move to Rack Rack Rack part Arm Fore Aft Not Arm Rack Still onpart way way Stuck F11 FD11 determined failure Storage Robot moved;moved; if part failure failure or if moving way Elevator moving out toaft OK rack out side to fore side. Action OK Message Service ServiceService Service Service Service Service to User to Call Call Call CallCall Call Call Check Rack and reinsert; After Retty Limit Call Service

Sensors are also provided in rack storage area 22 and I/O port 120 todetermine if a rack has been successfully transferred from the rackstorage area 22 or I/O port 120 area to the robot 320. The followingconditions after execution of a command to “move the rack onto the robotfrom the rack storage area” cause the specified status and actions.

IO Slot N Y N Y any any any N N N Y Sensor Out (Closer to User) IO SlotN N Y Y any Y any N N N Y Sensor In (Closer to Robot). Arm In In In InIn In Motion In In In Motion Home Error Error Sensors (In, Out, NA) ForeY Y Y N Y Y any N Y N Y FD-11 sensor (Y,N) Aft FD- Y Y Y N any any any YN N Y 11 sensor (Y, N) Mailbox N N N Y Y any any N N N N Inventory FD11(Y, N) Status Move IO IO Rack Rack Rack Arm Fore Aft Not Arm into SensorSensor Still in part part stuck FD11 FD11 determined failure robot OutIn mailbox way way part failure failure OK failure failure moved movedway Action OK User User Message Try to Try to Drop Service ServiceService Drop Message Message to Eject Eject down in Call Call Call downin to to User to Rack; Rack; Z; Z; check check Check Message MessageHome Home IO IO Rack User User Arm; Arm; Slot; Slot; and to to MessageMessage Service Service Reinsert; check check to to Call Call After RackRack user to user to Retry and and reload reload Limit Reload; Reload;rack; rack; Call Home After Close Close Service Robot; Retry IO IO AfterLimit Gate; Gate; Retry Call Wait Wait Limit Service for for Callcustomer customer Service reload; reload; (possible Retry Retry use ofOnce; Once; Auto Service Service Cal Call Call SW)

The system 10 provides the following actions in response to aninstruction to the robot 320 to move the rack into location in the rackstorage area 22 or I/O port 120.

IO Slot Y N Y N any any any Y N N Y Sensor Out (Closer to User) IO SlotY Y N N any Y any Y N N Y Sensor In (Closer to Robot). Arm Out to Out toOut to Out to Out to Out to Motion Out to Out to Out to Motion HomeEncoder Encoder Encoder Encoder Encoder encoder Error encoder encoderencoder Error Sensors count count count count count count count countcount (In, Out, NA) Fore N N N Y any any any N Y N Y FD-11 sensor (Y,N)Aft FD- N N N Y N N any Y N N Y 11 sensor (Y,N) Relevant Y Y Y N Y anyany Y N N N Mailbox Inventory FD11 (Y,N) Status Move IO IO Rack RackRack Arm Fore Aft Not Arm To Sensor Sensor Still part way part way stuckFD11 FD11 determined failure Rack Out In on moved; moved; part failurefailure Storage failure failure robot Arm Arm way OK mechanism mechanismfailure failure Action OK Service Service Call Drop Drop Drop ServiceService Service Retry Call; Call; Service down in down in down Call CallCall Once; Customer Customer Z; Home Z; Home in Z; then can can Arm;Arm; Home call run rest run rest Message Message Arm; Service of rack ofrack to user to to user to Message in in unload; unload; to SystemsSystems Call Call user to and and Service Service unload; unload;unload; Call Cannot Cannot Service load load anymore anymore beforebefore Service Service Visit Visit

The first pre-analytical processing deck 24 is equipped with a visionsystem in one embodiment. In this embodiment a camera acquires an imageof the racks on the processing deck. The image is evaluated to identifyerrors in the way the racks were loaded. Examples of such errors includepierced sample tubes, capping errors or racks with mixed containertypes. The image is compared with information stored in the system 10regarding the rack 30, 40, or 50, to ensure that the rack in the imageis the correct rack. If the rack is determined to have an error, it isassociated with an error in the system software and routed to rackstorage 22. The system 10 notifies the operator (via a graphical userinterface 820 or GUI described elsewhere herein) through anyconventional notification channel (audio/visual, text message, email,etc.) and advises that the rack with the associated error should beremoved from the system. The user can then enter a request that the rackbe returned via the interface 820 which causes the system 10 to instructthe rack handler robot 320 to retrieve the rack from storage 22 andconvey it to the I/O slot 120 of the system 10.

Suspended Robot Assembly

Referring back to FIGS. 1-3, suspended robot deck 28 includes asuspended robot assembly 400 which is configured to handle samples andsample containers located on first and second pre-analytical processingdecks 24, 26.

Suspended robot assembly 400, as shown in FIG. 16A, includes a pluralityof robots and a support beam or gantry 402. Support beam 402 is asupport beam that spans the length of system 10 in a left-rightdirection and is mounted to support components 21 of structural frame 20at opposite ends of support beam 402. When supported by frame 20,support beam 402 includes a front-side and a back-side. A rack 406 (of arack and pinion mechanism) and a rail 408 disposed directly below rack406 extend along the length of both the front and back-sides. A tray404, for cable management, is disposed at a top-side of support beam 402and extends along its length. This tray 404 is configured to receivecable sleeves 405 for electric cables feeding each robot as the robotsmove along support beam 402.

The plurality of robots includes three pick-and-place robots 410 a-c,two decapper robots 450 a-b, and a pipetting robot 480. From right toleft, front-side of support beam includes first pick-and-place robot 410a, first decapper robot 450 a, pipetting robot 480, and second decapperrobot 450 b. Addition, from left to right, the back-side of support beam402 includes second pick-and-place robot 410 b and third pick-and-placerobot 410 c. As described in detail below, each decapper robot 450 a-bperforms discrete functions within the pre-analytical system 10. In oneembodiment, the first capper/decapper is for the LBC type containers(types 01 and 02) and the second is for the sample buffer tubes (thethird type 03 containers).

Pick-and-Place Robots

FIG. 16B depicts a pick-and-place robot 410, which are virtuallyidentical for robots 410 a-c. The difference between these robots isthat pick-and-place robots 410 b and 410 c are configured to have ashorter length of travel than robot 410 a to retrieve items from secondpre-analytical processing deck 26 as this deck 26 is elevated relativeto first pre-analytical processing deck 24 over which robot 410 aoperates. Pick-and-place robot 410 generally includes a housing 412,control box 414, gripper assembly 430, and transport mechanism 420.

Transport mechanism 420 is mounted to housing 412 and extends from anopen-end thereof. Transport mechanism 420 includes a motor 424, one ormore pinions/idlers 422 (of the rack and pinion mechanism mentionedabove), and a rail mount 426. Motor 424 is connected to the one or morepinions 422 and is configured to rotate pinions 422 in any one of twoangular directions. Motor is mounted with a spring bracket (not shown)which keeps pre-load on the motor's gear and pinions 422. This creates azero-backlash or reduced backlash setup. Rail mount or linear profilebearing 426 is connected to housing 412 beneath pinions 422 so as toform a lipped opening 428 between rail mount 426 and pinions 422 whichis sized to receive rack 406 so that rack 406 indexes with pinions 422.A lip 429 partially defining lipped opening 428 creates a channel thathelps keep rack 406 aligned within lipped opening 428 when disposedtherein. Rail mount 426 is configured to slidingly attach to rail 408.

Gripper assembly 430 is attached to a side of housing 412. Inparticular, the side of housing 412 includes horizontal rails 416 a-bdisposed at a top-end and bottom-end of housing 412. A sliding plate 440is slidingly attached to both of horizontal rails 416 a and 416 b andincludes a vertical rail 442. When mounted to horizontal rails 416 a-b,sliding plate 440 and vertical rail 442 extend below horizontal rail 416a to extend a z-direction reach of gripper assembly 430. A belt andpulley mechanism 445 is attached to sliding plate 440 and drives slidingplate 440 forward and backward along horizontal rails 416 a-b.

Gripper assembly 430 includes a carriage 436 which is slidingly attachedto vertical rail 442 and drive shaft 448. Drive shaft 448 is operated bya motor 449 which is attached to a top-end of sliding plate 440 andmoves with the sliding plate 440 when belt and pulley mechanism 445 isoperated by a motor 446. Gripper assembly 430 also includes gripperfingers 432, such as two gripper fingers, which are operated by anothermotor 434 such that gripper fingers 432 move away from and toward eachother to grip sample containers of various sizes, such as containers 01,02, and 03. However, the gripper as utilized in system 10 typicallygrips and transports container 03.

Control box 414 is mounted to the inside of housing 412 and iselectrically coupled to a computing system (described below) and motors424, 434, 446, and 449. Control box 412 includes electronics thatreceive instruction signals from the computing system, converts theminto operating signals, and sends the operating signals to the variousmotors 424, 434, 446, and 449 to perform the instructed operations.Control box 414 also sends signals back to the computing systemregarding position of gripper assembly 430, task completion, and thelike.

In an exemplary method of operation, the computing system sendsinstructions to control box 414 to pick up a container, such ascontainer 03, from a first location and transport it to anotherlocation. These locations may be preprogramed or determined throughoptical sensors or other means disposed throughout system 10 thatdetermine the precise location of the target container. Control box 414receives these signals and converts them into operating signals whichare sent to motors 424, 434, 446, and 449 to perform the instructedtasks. Motors 424, 434, 446, and 449 are then operated concurrently orsequentially to move robot 410 along support beam 402, sliding plate 440along horizontal rails 416 b, carriage 442 along vertical rail 442, andgripper fingers 432 until the container is picked up and moved to thedesignated location.

Decapper Monitoring and Error Protocols

System 10 has a pick-and-place processor that controls operation ofpick-and-place robots 410 a-c. Such processor may be associated with theone or more processors 804 of the computer control device 802 of system10 described in more detail below. Also, as described below in moredetail, when a shuttle 280 is received from an analyzer module after thesamples contained therein are analyzed, a rack 50 is provided on theprocessing deck at location 110 for unloading the sample containers 03from the shuttle 280 to the rack 50. The pick-and-place robot 410 a, ascontrolled by the processor, unloads the containers 03 from the shuttle50. A feedback loop monitors the pick-and-place robot 410 a to determineif a sample container is unloaded from a position in the shuttle 280 toa position in the rack 50. If feedback indicates that no samplecontainer was unloaded from a position in shuttle 280, the system 10will send an error message.

If a container 03 has been successfully gripped, a feedback loop isprovided to ensure that the container 03 remains gripped. If thecontainer 03 is dropped, the system 10 pauses and an error message issent. If system 10 determines that the barcode on the sample containerneeds to be read, the pick-and-place robot 410 a moves the container toa container spinner (not shown) and deposits the container 03 therein sothat the container 03 can be spun in front of the scanner so that thecontainer can be read. Feedback loops are provided to determine if thepick-and-place robot 450 a moved the container 03 to the spinner/reader,seated the container 03 in the spinner, released the container 03, andwhether or not the container 03 was spun and the barcode was read. Ifmotion errors occurred at these steps there is one retry before afailure is indicated. In the above, there could be a gantry z/y-movementfailure, a gantry Z-movement failure, a gripper finger failure or aspinner failure. All failures, if indicated with cause the system 10 tostop operation.

If the barcode is not read successfully, then there may be a motorencoder error of the spinner. In retry, the container 03 is spun andread again. If retry is unsuccessful the container 03 is picked from thespinner. The empty spinner is subjected to a bar code test. If the readfails, the sequence is stopped and the failure data is stored. If thebarcode read test is successful, the container 03 is replaced in thespinner and barcode read is retried. If read is successfully, theprocess continues and the container chain of custody is reported. If thecontainer 03 is not read successfully the container 03 is flagged.

Once read, the container 03 is placed in a rack 50 at location 110.Again, the container 03 is moved to particular x, y coordinate, thenmoved down (in z) to be placed in its predetermined location in the rack50. The gripper 432 releases the container 03 and the gripper then movesback up in z to its travel height. If motion errors are detected for anyof these motions, then there is one retry. If still unsuccessful thenthere is a failure, and a stop operation occurs and the failure data isstored. Once the container 03 is released the grippers 432 are no longermonitored for droppage. Once the shuttle 280 is determined to be empty,it is returned to either docking station 260 a or 260 b.

Pick-and-place robot 410 a has its own power recovery protocol from asystem pause or stop. Again the discrete acts performed are to close thegripper 432 to retain a held container, send the robot 410 a to home onthe x, y and z axis. If motion errors are detected there is one retrybefore the system issues a stop operation and the failure data isstored. There is also recovery of the barcode reader. In this regard,there is then an empty spinner barcode retest. If read is unsuccessful,it is determined that there is a failure. A successful read willindicate that the barcode reader is ready.

Robot 410 a is moved in to the empty barcode spinner location and, ifsuccessful, the container 03 is seated in the spinner and if successfulthe gripper 432 is moved home. Motion errors, if detected, will allowfor one try prior to failure. If the barcode is successfully read then,the container in the spinner it is removed, and the container is movedto its designated rack position and placed in rack 50 as describedabove. Once the sequence is complete, the empty robot 410 a is moved toits safe location, power recovery is complete and the robot is ready foroperation.

The tube spinner and barcode reader described herein has a diagnosticself-test. As described elsewhere herein for other discretecomponents/apparatus/subsystems, the diagnostic self-test is performedin communication with a processor/controller and sensors that reportmotion errors at which time the processor/controller initiates a retry.If the retry is unsuccessful a report is given to the operator and,depending upon the programmed instructions, the module, apparatus orsystem may enter pause or shut down until the error is corrected.

Although, the above error protocols are describe with respect topick-and-place robot 410 a, it should be understood that robots 410 b-cmay also be operated with such protocols to perform diagnosticself-tests to resolve errors similar to the above.

Decapper Robots

FIG. 16C depicts a decapper robot 450, which is identical for robots 450a-b. Decapper robot 450 generally includes a housing 452, control box454, decapper assembly 470, and transport mechanism 460.

Transport mechanism 460 is mounted to housing 452 and extends from anopen-end thereof. Transport mechanism 460 includes a motor 464, one ormore pinions 462 (of the rack and pinion mechanism mentioned above), anda rail mount 466. Motor 464 is connected to the one or more pinions 462and is configured to rotate pinions 462 in any one of two angulardirections. Rail mount 466 is connected to housing 452 beneath pinions462 so as to form a lipped opening 468 between rail mount 466 andpinions 462 which is sized to receive rack 406 so that rack 406 indexeswith pinions 462. A lip 469 of lipped opening 468 creates a channel thathelps keep rack 406 aligned within lipped opening 468 when disposedtherein. Rail mount 466 is configured to slidingly attach to rail 408.

Decapper assembly 470 is suspended at a lower-end of housing 452 andgenerally includes two elongate fingers 472 attached to a series ofgears 474. Gears 474 are driven by a driveshaft (not shown) and adecapper motor 476 which moves fingers 472 closer or further away fromone another and also rotates all of fingers 472 about a central axis tode-cap/recap a container. Decapper motor 458, which may be disposed inits own housing, and decapper assembly 470 are attached to a slidingplate 456 via a vertical rail 458 located on a surface of sliding plate456. Sliding plate 456 is slidingly attached to a horizontal rail 455located on a support structure within housing 452. A series of othermotors (not shown) drive sliding plate 456 along horizontal rail 455 ina front-back direction and decapper assembly 470 along vertical rail458.

Control box 454 is mounted to the inside of housing 452 and iselectrically coupled to a computing system (described below) and motors464, 476 and the ones not shown. Control box 454 includes electronicsthat receive instruction signals from the computing system, convertsthem into operating signals, and sends the operating signals to thevarious motors to perform the instructed operations. Control box 454also sends signals back to computing system regarding decapper position,task completion, and the like.

In an exemplary method of operation, computing system sends instructionsto control box 454 to pick up a container, such as one of containers 01,02, and 03, from a first location (e.g., rack spaces 112, or 114/116),transport it to another location (e.g., primary or secondary containerstation), and de-cap and recap the container. These locations may bepreprogramed or determined through optical sensors or other meansdisposed throughout system 10 that can determine the precise location ofthe target container. Control box 454 receives these signals andconverts them into operating signals which are sent to motors 464, 476and the ones not shown to perform the instructed tasks. The motors arethen operated concurrently or sequentially to move robot 450 alongsupport beam 402, sliding plate 456 along horizontal rails 455, motor476 and decapper assembly 470 along vertical rail 458, and decapperfingers 472 together until the container is picked up and moved to thedesignated location. The designated location preferably includesengagement features, such as those within primary or secondary containerstations 140, 150, or a clamping mechanism, such as clamp assembly 160that restrains the container from rotation. Once the container isconstrained, decapper assembly 470 is rotated to de-cap container.Fingers 472 hold onto the cap and recap the container when ready.

Decapper Monitoring and Error Protocols

System 10 has a decapper processor that controls operation of decapperrobots 450 a-b. Such processor may be associated with the one or moreprocessors 804 of the computer control device 802 of system 10 describedin more detail below. In addition, the decapper processor has processinglogic that identifies errors and implements preprogrammed error processflows. As described elsewhere herein, as part of the error process flow,motions of each decapper 450 a-b are monitored for motion errors. Ifmotion errors are detected, then one retry is permitted before there isan error message or corrective action taken. When a decapper isinstructed to move its gripper fingers 472 to the pre-grip/homeposition, the decapper is directed to a location and settings based uponthe type of container to be capped or de-capped. If a z-motion error isdetected, a retry is performed before an error message issues as notedabove. If the decapper stalls in the z-motion, the grippers 472 are allre-homed. Motion errors detected on re-homing allow for one retry withensuing error message upon detecting a second motion error. Othermotions monitored for motion errors include x and y movements to acontainer barcode reader, rotational/spin movements (for readingbarcodes) and the barcode read itself. Also, the movement of thecontainer's cap is monitored to detect a dropped cap should it occur.

The spin motion of the decapper is also monitored for motion errors. Ifrotation stalls repeatedly (more than twice in a row), the operator isnotified of a potential problem (e.g. a container size mismatch).Specifically, if rotation stalls this can indicate that the container isnot seated properly in the container receptacle (i.e. the nest for thecontainer).

The recap error flows also monitor for motion errors and only issueerror messages if the error occurs after one retry. The recap sequencecauses the decapper 450 to proceed to an x, y position above thecontainer to be re-capped, followed by transfer of a drip tray to ensurethat it does not impede motion of the decapper. This is further followedby moving the decapper 450 into position in the z direction. If there isa motion error in z, the decapper moves back to home in z.

The decapper 450 also has the ability to determine if a container isproperly re-capped by monitoring motor encoder counts and motor currentat appropriate segments during the re-cap routine. If the number ofrecap fails exceeds a certain threshold, the system 10 may stop andinform the operator. The container is cleared. After clearing, thedecapper 450 is rehomed. Failure to return home indicates that thedecapper 450 or the decapper assembly 470 needs to be replaced.

Once the cap is successfully tightened onto the container, the cap isreleased by the decapper 450.

The pre-analytical system 10 described here, in one embodiment, has apre-programmed routine for rebooting the decapper after a power outage.The decapper 450 has preset home positions (e.g. home position in x, yand z) to which the decapper 450 moves during a reboot/power restore. Ifthe decapper 450 was in the process of de-capping or re-capping duringpower failure, rotation is activated to uncap fully, and then thedecapper returns to the home position in z.

Pipetting Robot

Referring back to FIG. 16A, pipetting robot 480 includes a pipette arm481 and a pipette head 500. Pipette arm 481 includes a housing 483,control box 482, and transport mechanism similar to that ofpick-and-place robot 410. As such, transport mechanism includes a pinionand rail mount (not shown) that mounts to rack 406 and rail 408 ofsupport beam 402 at a front-side thereof for traversing support beam 402in a left-right direction. In addition, pipette arm 481 includeshorizontal rails 486 and a sliding plate 484 slidingly attached tohorizontal rails 486 similar to that of pick-and-place robot 410.Pipette head 500 is connected to a vertical rail (not shown) of slidingplate 484 and to a motor 488 via a drive shaft 487. Motor 488 isattached to sliding plate 484 so as to move with pipette head 500 assliding plate 484 is driven along horizontal rails 486 in a front-backdirection via a belt and pulley mechanism (not shown). Thus, as shown,pipette head 500 is coupled to pipette arm 481 via a z-axis drivemechanism that includes a vertical rail motor 488, and drive shaft 487.

Pipette head 500 generally includes a main board 501 and a pipetteassembly 502 (best shown in FIG. 16A). Pipette assembly 502 is comprisedof a pipette channel assembly and a pipette tip ejector assembly (bestshown in FIGS. 17A-17D). The pipette channel assembly includes a channelhousing 510, pipette tip adaptor 520, control unit 515, and connectorarm 517.

Channel housing 510 includes a pipette channel 522 extendingtherethrough (best shown in FIG. 17D). Housing 510 has a first sidesurface which is configured for connection to an ejector housing 540,and a second side surface which is configured to connect to control unit515. As depicted, channel 512 extends through a bottom end of housing510, extends along a portion of the length of housing 510, turns at anangle (such as between 90 and 180 degrees) and extends through thesecond side surface of housing 510.

Pipette tip adaptor 520 extends from the bottom of channel housing 510such that a channel 522 of pipette tip adaptor 520 is in fluidcommunication with channel 510 of channel housing 510 to form a unitarypipette channel In the embodiment shown, an isolator 528 for capacitivesensing couples pipette tip adaptor 520 to channel housing 510. However,in other embodiments, tip adaptor 520 may be directly connected tochannel housing 510.

At a bottom end of pipette tip adaptor 520 remote from channel housing510, pipette tip adaptor 520 includes first and second pipette tipengagement features 524, 526. In the embodiment depicted, theseengagement features 524, 526 are spherical bulbs that project radiallyoutwardly from adaptor 520. First engagement feature 524 has a smallerdiameter than second engagement feature 526. This helps create aninterference fit with a disposable pipette tip 489 for retaining tip 489to adaptor 520. In other embodiments, engagement features 524, 526 canbe conical portions like that of a Leuer lock or some other taperinggeometric feature.

Control unit 515 is connected to the second surface of channel housing510 and extends therefrom. Pipette channel 512 extends into control unit515 where a valve, such as a solenoid valve (not shown), selectivelyopens and closes channel 512. In one embodiment, differential pressureflow sensors (not shown) are located upstream of the valve and measureair flow to channel 512 to help control aspiration and dispense of asample in conjunction with the valve.

Connector arm 517 is coupled to control unit 515 and in particular tochannel 512. Connector arm 517 may be directly connected to control unit515 or may be located remote of control unit 515. Connector arm 517includes two inlet ports 518, 519. First inlet port 518 is a positivepressure port. Second inlet port 519 is a vacuum port. Positive andnegative pressures of air across these ports 518, 519 help driveaspiration and dispense of a sample.

Pipette tip ejector assembly generally includes a first ejector housingor upper ejector housing 530, a second ejector housing or lower ejectorhousing 540, a tip ejector 550, control unit 594 and a tip ejector drivemechanism.

First or upper ejector housing 530 includes an opening extendingtherethrough from a first end to second end thereof. The opening isdimensioned to receive a motor drive shaft 592 through the first end, anangular contact bearing 534 within the second end, and a shaft coupling536 within housing 530 between the first and second ends. A transverseport 532 extends into housing 530 and intersects the opening such thatwhen shaft coupling 536 is disposed within first ejector housing 530,shaft coupling 536 is exposed. This allows a motor 590 to be decoupledfrom pipette head 500 and replaced with minimal disassembly. Housing 530is also configured to connect to control unit 594 at one side thereof.

Second or lower ejector housing 540 is connected to the second end ofupper ejector housing 530 such that a longitudinal opening 542 of lowerejector housing 540 is in fluid communication with the opening of upperejector housing 530. Longitudinal opening 542 extends through the entirelength of lower ejector housing 540 from a first end or upper end to asecond end or lower end. Longitudinal opening 542 has a first portion orlower portion 543 smaller than a second portion or upper portion 541 soas to form a shoulder 545 therebetween (see FIG. 17D). A recess 544extends into the second end of housing 540. A Hall Effect sensor 548 isembedded in housing 540 adjacent to recess 544.

A side surface 546 extending along the length of housing 540 isconnected to main board 501 (FIG. 16A). Main board 501 may includeelectrical connections and other connections for pipette head 500 andconnects pipette head 500 to pipette arm 481 via the z-axis mechanism.The connection between pipette assembly 502 and main board 501 may be arigid connection or hinged connection, such as via a hinge located in anotch 549, so that pipette assembly can be rotated about a vertical axisinto other positions. In addition, housing 540 has a cut-out portion 547at one side thereof which receives a portion of pipette channel housing510.

Tip ejector 550 includes a cannulated body 552 and an arm 554 extendingfrom body 552. Cannulated body 552 has an opening extending therethroughfrom a first to second end and is dimensioned to slidingly receive tipadaptor 520. Arm 554 extends from an upper end of cannulated body 552and has an elbow 557 defining a curve in arm 554 of about 90 degrees,which forms a horizontal portion 556 and a vertical portion 558.Horizontal portion 558 is configured to attach to a floating shaft 560.A terminal end 559 of vertical portion 558 remote from horizontalportion 556 is sized to be partially received in recess 544 of lowerejector housing 540. In addition, a magnet 551, configured to cooperatewith Hall Effect sensor 548, is located in terminal end 559 of verticalportion 558. This magnet 551 cooperates with Hall Effect sensor 548 todetermine whether a pipette tip is retained on tip adaptor 520.

The tip ejector drive mechanism includes a motor 590, lead screw 580,pusher nut 570, and floating shaft 560. Motor 590 is an electric motorwhich may include an encoder and gearbox integrated therewith. A motordrive shaft 592 extends from motor 590.

Lead screw 580 includes an upper portion 582, lower portion 586, andintermediate portion 584. Upper portion 582 and lower portion 586 have asmaller diameter than intermediate portion 584 which helps retainbearing 534 and provides a backstop for pusher nut 570. In addition,upper portion 582 is configured to attach to drive shaft 592 viacoupling 536 and has generally smooth outer surfaces for rotation withinangular contact bearing 534. Lower portion 586 is threaded along itslength for driving pusher nut 570.

Pusher nut 570 is internally threaded and externally dimensioned to bereceived within upper portion 541 of longitudinal opening 542. A lowerend of pusher nut 570 has generally flat surfaces for pushing againstfloating shaft 560.

Floating shaft 560 has a head 562 with a larger diameter than a shank564 thereof. The shank diameter is sufficiently small as to be slidinglyreceived within lower portion 543 of longitudinal opening 542. Head 562has a diameter sufficiently large as to prohibit being received withinlower portion 543 of longitudinal opening 542 while sufficiently smallas to be slidingly received within upper portion 541 of longitudinalopening 542. A lower end of shank 564 remote from head 562 is configuredto attach to horizontal portion 556 of tip ejector 550, such as byreceiving a fastener extending from horizontal portion 556.

Control unit 594 is connected to upper ejector housing 530 and has anoutput coupled to motor 590 for driving motor 590 in one of tworotational directions. Control unit 594 also has an input connected toHall Effect sensor 548 and an output that is coupled to the computingsystem (described below) to notify a user that a pipette tip has fallenoff of tip adaptor 520. Additionally, control unit 594 can be a switchinterface board (“SIB”) to provide switching functionality to pipetteassembly 502.

As assembled, the pipette channel assembly is connected to the pipetteejector assembly via channel housing 510 being received in cutoutportion 547 of lower ejector housing 540 and is connected thereto. Inthis regard, tip adaptor 520 extends below both channel housing 510 andlower ejector housing 540.

Shank 564 of floating shaft 560 is received within lower portion 543 oflongitudinal opening 542 such that an end of shank 564 extends fromlower ejector housing 540. Tip adaptor 520 is received within theopening of the cannulated body 552, horizontal portion 556 is connectedto an end of shank 564, and terminal end 559 of vertical arm 558 isreceived within recess 544 of lower ejector housing 540.

In this regard, floating shaft 560 and tip ejector 520 have a tip-offposition and tip-on position. In the tip-off position, no pipette tip isconnected to tip adaptor 520, and in the tip-on position, a pipette tipis connected to tip adaptor 520.

When in the tip-off position, head 562 of floating shaft 564 restsagainst shoulder 545 of lower ejector housing 540. This positionscannulated body 550 at its lowest extent or near its lowest extentrelative to tip adaptor 520 such that body 552 surrounds one or both offirst and second engagement features 524, 526. In addition, terminal end559 and magnet 551 are positioned at their lowest extent within recess544.

When in the tip-on position, a pipette tip pushes cannulated body 552upward such that cannulated body 552 is positioned above first and/orsecond engagement feature 524, 526, terminal end 559 of vertical portion558 is positioned above its lowest extent within recess 544, and head562 of floating shaft 550 is positioned a distance above shoulder 545.It should be understood that when no pipette tip is attached to tipadaptor 520 (illustrated), floating shaft 560 and tip ejector 550 arepositioned in the tip-off position under their own weight. Also, when apipette tip is attached to tip adaptor 520, the weight of floating shaft560 and tip ejector 550 are countered by the holding force between tipand tip adaptor 520 so as to position floating shaft 560 and tip ejector550 in the tip-on position.

Continuing with the assembly, pusher nut 570 is positioned above head562 of floating shaft 560 within upper portion 541 of longitudinalopening 542. Lower portion 543 of leadscrew 580 is threaded to pushernut 570 and extends therefrom such that upper portion 582 of leadscrew584 extends through angular bearing 534 positioned within the second endof upper ejector housing 530. Upper portion 582 of leadscrew 580 iscoupled to motor drive shaft 592 via coupling 536, and motor 590 ismounted to the first end of upper ejector housing 530.

Pusher nut 570 has an eject position and a stand-off position. In theeject position, the threads of leadscrew 580 position pusher 570 withinlongitudinal opening 542 such that pusher nut 570 forces floating shaft560 and tip ejector 550 into the tip-off position. In the stand-offposition, the threads of leadscrew 580 position pusher 570 withinlongitudinal opening 542 such that floating shaft 560 has sufficientspace to allow a pipette tip to be connected to tip adaptor 520.

A method of operation of pipette head 500 is now described. In themethod, robot 480 is moved along support beam 402 to pipette tip rackslocated at space 180. Tip adaptor 520 is aligned with a pipette tip 489and motor 488 drives pipette head 500 toward pipette tip until tipadaptor 520 engages an opening of pipette tip 489. Motor 488 furtherdrives tip adaptor 520 into the opening of pipette tip 489 so as toengage one or both engagement features 524, 526 in a locking fashion. Asthis occurs, an end of pipette tip 489 pushes against cannulated body552 which drives floating shaft 560 upwardly so that head 562 lifts offof shoulder 545 to form a distance therebetween. In addition, terminalend 559 of vertical portion 558 moves upwardly within recess 544 andmagnet 551 interacts with Hall Effect sensor 548 which sends a signal tocontrol unit 594 that indicates a pipette tip 489 is engaged. At thisstage, floating shaft 564 and tip ejector 550 are in the tip-onposition.

Robot 480 then moves along support beam 402 to aspirate a sample from acontainer. If at any time pipette tip 489 inadvertently falls off of tipadaptor 520, floating shaft 564 and tip ejector 550 automatically moveinto the tip-off position. The movement of magnet 551 into this positionsignals control unit 594 that tip 489 has fallen off of tip adaptor 520and a user is warned of this occurrence. Stated another way if tip 489accidentally falls off of tip adaptor 520, the weight of tip ejector 550and floating shaft 560 causes cannulated body 552 to slide downwardlyalong tip adaptor 520, floating shaft 560 to drop so that head 562contacts shoulder 545, and terminal end 559 to move downwardly withinrecess 544 which triggers a tip-off warning.

Once robot 480 reaches an open sample container, motor 488 drives tipadaptor 520 down until tip 489 contacts the sample which triggers acapacitive or pressure-based liquid level detection sensor causingaspiration to begin. After a sample has been aspirated and dispensed inanother container, pipette head 500 is moved to an opening locatedthrough first pre-analytical processing deck 24. With pipette tip 489aligned over the opening, motor 590 turns on which drives leadscrew 580in a first direction from a stand-off position to an eject position. Thethreads of leadscrew 580 push pusher nut 570 toward head 562, which ispositioned above shoulder 545. When pusher nut 570 contacts head 562,pusher 570 is further driven which pushes floating shaft 560 downward.Shank 564 pushes on horizontal portion 556, which consequently pushesbody 552 downwardly along tip adaptor. Body 552 drives pipette tip 489off of engagement features 524, 526 so that pipette tip 489 is ejectedfrom tip adaptor 520. When ejection occurs, the weight of floating shaft560 and tip ejector 550 causes head 562 to fall whatever remainingdistance there is left between head 562 and shoulder 545, which signalsthat tip 489 has been successfully removed. Since tip 489 is ejectedover an appropriate waste opening, no alarm is signaled. Motor 590 isthen operated in a second direction which returns pusher nut 570 to thestand-off position so that another pipette tip can be attached to tipadaptor 520.

If the robotic pipettor drops a pipette before it reaches the wastereceptacle, the robotic pipettor returns to its home position and opencontainers are recapped, prior to the capper/decapper robots 450returning to their respective home positions.

Pipette Monitoring and Error Protocols

System 10 has a pipettor processor that controls operation of pipettingrobot 480. Such processor may be associated with the one or moreprocessors 804 of the computer control device 802 of system 10 describedin more detail below. Pipettor processor/controller provides both powerrestore protocols and error control protocols to the pipettor 480. Asnoted previously herein, errors in motion, when detected, are given oneretry before the system logs an error and informs an operator.Additional pipettor errors include aspiration and clogged pipette tips.

During sample preparation/conversion, the pipettor 480 is instructed toretrieve a pipette tip 489. The pipettor 480 conducts various checksprior to and after picking up a tip, including flow check of the newlypicked up tip as the pipettor 480 is advanced to the sample container toobtain an aliquot of sample for preparation/conversion. When called toeject a tip, if the tip fails to eject after the first try, thecontroller runs a preprogrammed routine for a tip eject failure. If thetip sensor 548 indicates an error with the tip pick up, the pipettor 480is returned to home, and there is a retry. If the tip sensor 548 againindicates that there was an error with tip pick up, a different rack ofpipette tips is tried. If the error persists, or another rack of tips isnot available, preparation/conversion is paused until the problem issolved.

Sample containers 01, 02, and 03 are de-capped using the procedures anderror control protocols described elsewhere herein. The diluent bottles14 are monitored and, if the bulk diluent bottle level is low, a messageis sent to the operator. The diluent contained in such bottles 14 isthen dispensed into the third-type containers 03 for samplepreparation/conversion. The dispense head 174 is used to dispensediluent into a container and to monitor the level of diluent in thecontainer. If a motion error is detected, there is a level check retryand if the error persists then the bulk diluent head 174 is evaluatedfor errors. If the bulk diluent head 174 successfully checks the levelof the diluent dispensed into the container, then the sample containeris de-capped. If the diluent level is too low or too high, there is oneretry followed by, if unsuccessful, a message to the operator to stopusing the channel 175 if the level is too high and the container 14 isdiscarded. If the level remains too low, the container 14 is discarded.

The z-motion of the pipettor 400 is monitored. If the pipettor 400 failsto encounter the liquid level surface for an aspiration, there is oneretry before the sample is recapped, returned to the sample storage area22 and designated as a bottle with no sample. The container 03 intowhich the sample was to be dispensed is discarded.

If the liquid level surface is in contact with the pipette tip 489, theZ position of the pipette tip 489 is reported and compared with aminimum threshold for the container type. If below the minimumthreshold, the pipette tip 489 is moved to the bottom and then raisedabout 0.5 mm in the z-direction. During aspiration the pipette tip 489can either remain at a z-coordinate or travel downward in thez-direction as aspiration progresses and the liquid level declines.Z-motion errors and aspiration errors initiate further protocols.Z-motion errors will allow one retry before entering an error protocolfor pipette channel z failure. Aspiration errors will cause a retry inwhich the pipettor 480 will move incrementally in x, y, or z directionsafter which aspiration will occur at a lower rate. If aspiration errorscontinue and the liquid level is below threshold than the pipette tip489 contents are redispensed into the sample container which is recappedand sample reported as low volume. If the liquid level is not belowthreshold, then the sample is redispensed and the sample is replaced andthe aspiration error is reported as a clog.

Upon successful aspiration, the pipettor 480 will pull a travel air gapand, after a pause to let drips fall into the container, the pipettor480 will move to the dispense location. If there is an x, y or z motionerror, there is one retry before an axis error is indicated.

The dispense is then monitored for errors. If a dispense error occurs,the container 03 designated to receive the dispensed liquid isdiscarded. The tip 489 is then discarded. If no dispense error, the tip489 is discarded, the sample container and prepared sample container arerecapped and moved to their respective racks. If the prepared samplecontainer is prepared correctly it is recorded in the system 10 as suchand sample preparation is complete and a secondary sample is obtainedfor further pre-analytical processing.

Main Deck Robot Operating Envelopes

FIG. 18 depicts the operating envelopes 610 a-c, 650 a-b, and 680 ofeach robot 410 a-c, 450 a-b, and 480 of suspended robot assembly 400relative to first and second pre-analytical processing decks 24, 26.Robots 410 a-c, 450 a-b, and 480 generally perform their assignedresponsibilities within these envelopes which facilitates efficientperformance as the envelopes help minimize the distance robots 410 a-c,450 a-b, 480 must travel to perform their assignments and helpscoordinate robot movement as they traverse support beam 402. While theserobots generally operate within these envelopes they are not preventedfrom travelling outside of the envelopes.

As shown, operating envelope 610 a for pick-and-place robot 410 a isestablished over first pre-analytical processing deck 24 and about firstsample rack space 110 and third shuttle docking station 260 c of shuttlehandling assembly 240. Robot 610 s operates within this envelope 610 ato transfer sample containers 03 from a shuttle 280 at third shuttledocking station 260 c (FIG. 12A) to a rack 50 located at first samplerack space 610 a.

Operating envelope 650 a for first decapper robot 450 a is establishedover first pre-analytical processing deck 24 and about second samplerack space 112 and sample preparation/conversion assembly 130. Robot 450a operates within this envelope 650 a to transfer containers 01 and 02between racks 30 and 40, respectively, and primary sample containerstation 140. Decapper 450 a also de-caps and recaps containers 01 and 02within this envelope 650 a. In addition, decapper 450 a positions thesecontainers 01 and 02 in view of a barcode scanner (not shown) atpreparation/conversion assembly 130 so that the barcode scanner can scanthe containers.

Operating envelope 680 for pipetting robot 480 is established abovefirst pre-analytical processing deck 24 about pipette tip rack space 180and sample preparation/conversion assembly 130. Robot 480 operateswithin this envelope 680 to retrieve and dispose of disposable pipettetips and to aspirate and transfer an aliquot from a primary first-typeor second-type container 01, 02 at primary sample container station 140to a secondary first-type container 03 at secondary sample containerstation 150.

Operating envelope 650 b for second decapper robot 450 b is establishedabout sample preparation/conversion assembly 130, pipette tip rack space180, and third and fourth sample rack spaces 114/116. Robot 450 boperates within this envelope 650 b to transport empty third-typecontainers 03 and third-type containers 03 inoculated with a controlfrom a rack 50 located at third rack space 114/116 to and from secondarysample container station 150. Second decapper robot 450 b also de-capsand recaps these containers within this envelope 650 b. In addition,decapper 450 b positions these containers in view of a barcode scannerso that barcode scanner can scan an identifying barcode.

Operating envelope 610 b for second pick-and-place robot 410 b isestablished over second pre-analytical processing deck 410 c and aboutspace 200, barcode scanner 205, batch-accumulation area 210, andvortexers 220. Robot 410 b operates within this envelope 610 b totransfer primary and secondary third-type containers 03 among a rack 50located at space 200, receptacles 212 within batch accumulation area210, and bulk vortexers 220. In particular, robot 410 b generallytransfers containers 03 from space 200 to the batch accumulation area210 and from batch accumulation area 210 (or directly from space 200) tobulk vortexers 220. Robot 410 b also positions these containers 03 inview of a barcode scanner (not shown) at preparation/conversion assembly130 so that the barcode scanner can scan the containers.

Operating envelope 610 c for third pick-and-place robot 410 c isestablished over second pre-analytical processing deck 26 and aboutbatch-accumulation area 210, bulk vortexers 220, warmer 230, cooler 290and first and second shuttle docking stations 260 a, 260 b. Robot 410 coperates within this envelope 610 c to transfer primary and secondarythird-type containers 03 among the above identified instruments andlocations. In particular, robot 410 c generally transfers container 03from batch accumulation area 210 and bulk vortexers 220 to warmer 230,cooler 290 and shuttle handling assembly 240. So while secondpick-and-place robot 410 b generally transfers containers 03 to bulkvortexers 220 and batch-accumulation area 210, third pick-and-placerobot 410 c generally transfers containers 03 away from bulk vortexers220 and batch accumulation area 210.

System Modules

FIG. 19 depicts several modules 710, 720, 730, 740, 750 that are groupsof many of the above identified instruments and locations/spaces thatwork together as subsystems within system 10 to perform generalfunctions. In other words, each instrument and location/space isassigned one or more specific functions and when operated in conjunctionwith other instruments and locations/spaces within a module, moregeneral functions are achieved which further the total operation ofsystem 10. As shown, system 10 includes an I/O and post analysis module710, sample conversion/preparation module 710, pre-preprocessing module720, preprocessing module 740, shuttle processing module 750, andconsumable accumulation module 760.

Input/Output and Post Analysis Module

I/O and post analysis module 710 is both a start-point and end-point ofsystem 10. Stated another way, consumables enter into system 10 throughmodule 710 and flow through system 10 within one of several routes whichleads back to this module 710, thereby closing a travel loop. Module 710includes I/O port 120, first sample rack space 110, container elevator100, third shuttle docking station 260 c, and first pick-and-place robot410 a.

Within this module 710, I/O port 120 receives every rack and samplecontainer from a user and outputs these racks to a user when commanded.For example, I/O port receives sample racks 50 with empty third-typecontainers 03 later to be used as secondary sample containers, sampleracks 50 with third-type containers 03 inoculated with controls, sampleracks 50 with primary third-type sample containers 03, sample racks 30with primary first-type sample containers 01, sample racks 40 withprimary second-type sample containers 02, and pipette tip racks 182loaded with disposable pipette tips.

I/O port 120 also outputs sample racks 50 with used primary third-typecontainers 03 that have gone through an analyzer, sample racks 50 withused primary third-type containers 03 that have gone through ananalyzer, sample racks 50 with used third-type containers 03 withcontrols therein that have gone through an analyzer, sample racks 30with primary first-type sample containers 01 that have had an aliquotextracted therefrom, sample racks 40 with primary second-type samplecontainers 02 that have had an aliquot extracted therefrom, and emptydisposable pipette tip racks 182.

Module 710 also receives shuttles 280 returning from one or moreanalyzers A₁ . . . A_(n) and optionally seals containers disposedtherein for storage. For example, a shuttle 280 is received at thirdshuttle docking station 260 c and containers therein are transferred toa rack 50 at first sample rack space 110 where they are sealed byelevator 100.

Sample Conversion/Preparation Module

Sample conversion/preparation module 720 includes second, third andfourth rack spaces 112, and 114/116, pipette tip rack space 180, samplepreparation/conversion assembly 130, decapper robots 450 a-b, andpipetting robot 480. Module 720 converts samples from primary containersto secondary containers. Sample preparation/conversion generallyincludes matching barcodes of primary and secondary containers,transferring an aliquot from a primary container to a secondarycontainer, diluting the aliquot with an assay specific diluent, andvortexing the containers. This module 720 also fills a rack 50 at thirdspace 114 with secondary third-type containers 03 and mixes in one ormore controls as desired. Such rack 50 is moved from sampleconversion/preparation module 720 to pre-preprocessing module 720.

Pre-Preprocessing Module

Pre-preprocessing module 730 includes space 200 for a rack 50,batch-accumulation area 210, barcode scanner 205, bulk vortexers 220 andsecond pick-and-place robot 410 b. Pre-preprocessing module 730 vortexesand accumulates secondary third-type containers 03 and controls afterthey leave conversion module 720. In addition, pre-preprocessing module730 vortexes and accumulates primary first-type containers 03 thatbypass preparation/conversion module 720 (discussed further below).These containers 03 are accumulated into batches for ultimatedistribution to an analyzer. For example, an analyzer may have acapacity to perform a particular assay on a batch of up to 36containers. Pre-preprocessing module 730 identifies the assay to beperformed for samples within each container 03, suspends particulateswithin the samples, determines whether the samples requirepreprocessing, and accumulates assay specific batches of 36 containers03 or less prior to being moved to preprocessing module 740 and/orsample transfer module 750. For example, pre-processing module mayaccumulate a batch of 12 or 24 primary and/or secondary containers 03.In another example, pre-processing module may accumulate batchescontaining 30 primary and/or secondary containers 03 and two controlcontainers.

Preprocessing Module

Preprocessing module 740 preprocesses a portion of the sample containers03 that leaves pre-preprocessing module 720. Preprocessing includespre-warming and cooling samples prior to distribution to an analyzer.Although in some embodiments of system 10 other preprocessing operationscan be included within this module, such as inoculation of samples withmagnetic beads. Module 740 includes warmer 230, cooler 290, and thirdpick-and-place robot 410 c. Whether or not samples are preprocessedgenerally depends on the assay to be performed on the batch of samples.In addition, the amount of time the samples are pre-warmed and cooledgenerally depends on the assay to be performed. For example, warming maybe performed at about 100 to 115 degrees Celsius for about 9 to 17minutes after equilibration at 100 degrees Celsius. In addition, coolingmay be performed for about 20 minutes or less or until the samples reacha temperature of about 40 degrees Celsius.

Shuttle Processing Module

Shuttle processing/transport module 750 loads batches or partial batchesof samples leaving pre-preprocessing module 720 or preprocessing module740 into shuttles 280 and distributes them to analyzers. Shuttleprocessing module 750 includes shuttle handling assembly 240 and shuttletransport assemblies 300 a-b.

Consumable Accumulation Module

Consumable accumulation module 760 (shown in FIG. 2) includes storagedeck 22, rack handler robot 320, and rack elevator 360. Module 760stores and accumulates system 10 consumables and distributes them to andfrom first and second pre-analytical processing decks 24, 26. Forexample, module 760 stores and accumulates about 40 racks or less, butpreferably 36 or less, and about 8 or less bulk diluent containers. Suchracks can include sample racks 30, 40, and 50 and pipette tip racks 182.This module helps provide inventory sufficient to allow for unattendedoperation of the apparatus for up to an entire work shift. It alsoallows a user to input and retrieve racks at random intervals throughoutthe work shift so that a lab technician can quickly move on to othertasks.

Computing System

FIG. 20 depicts a general architecture of an internal computing system800. Computing system 800 includes one or more computer control devices802, a user control/input interface 810, display interface 820 and a bus801. Bus 801 connects user interface 810, computer control device 802,and modules 710, 720, 730, 740, 750 so that user interface 810 and themodules can communicate back and forth with computer control device 802.In addition, analyzers 830, 840 can be modularly connected to bus sothat analyzers can communicate back and forth with processor 804.

Computer Control Device & Processor

Computer control device 802 may be any general purpose computer and maycontain a processor 804, memory 806 and other components typicallypresent in general purpose computer control devices. Although computercontrol device 802 can include specialized hardware components toperform specific computing processes. Processor 804 may be anyconventional processor, such as a commercially available CPU.Alternatively, processor 804 may be a dedicated component such as anapplication specific integrated circuit (“ASIC”) or other hardware-basedprocessor.

Memory

Memory 806 may store information accessible by processor 804, includinginstructions 808 that can be executed by processor 804. Memory 806 canalso include data 809 that can be retrieved, manipulated or stored byprocessor 804. Memory 806 can be of any non-transitory type capable ofstoring information accessible by processor 804, such as a hard-drive,memory card, ROM, RAM, DVD, CD-ROM, write-capable, and read-onlymemories.

Instructions 808 can be any set of instructions to be executed directly,such as machine code, or indirectly, such as scripts, by processor 804.In that regard, the terms “instructions,” “application,” “steps,” and“programs” can be used interchangeably herein. Instructions 808 can bestored in object code format for direct processing by processor 804, orin any other computing device language including scripts or collectionsof independent source code modules that are interpreted on demand orcompiled in advance.

In one embodiment of system 10, computing system 800 may include severalsets of instructions that are each associated with a mode of operation.For example, computing system 800 may include a load mode and unloadmode.

The load mode includes a set of load instructions that instruct theprocessor, in conjunction with user inputs, to perform certain tasksrelating to loading consumables into system 10. For example, when a userselects input mode, processor 804 may run a set of instructions 808 inwhich processor 804 asks the user, via display interface 820, toidentify the contents of the sample containers (e.g., controls, emptysample containers, or samples) and then digitally tags a rack holdingthese containers with the user identified information when it is loadedinto system 10 through I/O port 120 by the user. Further loadinstructions operate rack handler robot to move the rack to a rackstorage position in rack storage space 22. Processor 804 is furtherinstructed by the set of load mode instructions to digitally tag eachsubsequent rack loaded into system 10 and to move such rack to storagedeck 22 the same way until a user selects another option or changes themode.

The unload mode is a set of instructions that instruct processor 804 toperform certain tasks relating to unloading consumables from system 10in conjunction with user inputs. For example, when a user selects unloadprocessor 804 asks the user, via display interface 820, which samplecontainer the user would like to unload. After the user inputs thedesired information, further unload instructions operate rack handlerrobot 320 to deliver the rack containing the sample container to I/Oport 120.

The user loads the samples without having to individually interact witheach tube. The system individually scans each sample tube and looks upwhat tests have been ordered for that tube by interacting with computingsystem 800. Consumables, such as pipettes, for example are those itemsthat are used by the instrument to perform testing but are not patientsamples or used to transport patient samples to and from an assay, arenot managed by the computing system 800 or known to the computing system800. The difference between Samples/Empties will be indicated by theuser at the front of the machine (default to sample, special selectionfor empties) and will be confirmed by the instrument. Controls will beloaded in a rack with the same size and shape but will have a specialbarcode so that the instrument will know that the user is loadingcontrols.

Data is entered and viewed through a graphical user interface (“GUI”).Data includes, but is not limited to, diluent composition of bulkdiluent containers, sample container type, aliquot volume, assay to beperformed, patient information, preprocessing parameters (e.g., warmingtime, warming temperatures, cooling time, and cooling temperatures),dilution parameters for a sample (e.g., diluent composition and volume),and analyzer information (e.g., analyzer location relative to system 10,analyzer assay menu, and analyzer batch capacity).

This data can be digitally tagged to particular identification codes(e.g., barcode serial numbers) in a field implemented or relationaldatabase, which may also be stored in memory 806. This helps system 10keep track of various consumables within system 10 and helps providecertain information to processor 804 during the execution of processorinstructions 808 without the need for user input. For example, a rack30, 40, or 50 may have an identification code which may be tagged withcertain stored data such as the type of containers disposed therein. Inanother example, a sample container 01, 02, or 03 may have anidentification code which may be tagged with certain stored data such aspatient name, assay to be performed, preprocessing parameters anddiluent parameters. In a further example, an analyzer coupled to system10 may have an identification code which may be digitally tagged withanalyzer information.

Although FIG. 20 functionally illustrates processor 804, memory 806, andother elements of computer control device 802 as being within the sameblock, computer control device 802, processor 804, and/or memory 806 canbe comprised of multiple processors, computer control devices, andmemories, respectively, which may or may not be stored within the samephysical housing. For example, memory 806 can be a hard drive or otherstorage media located in housings different from that of computercontrol devices 802. Accordingly, references to processor 804, computercontrol device 802, and memory 806 should be understood to includereferences to a collection of processors, computer control devices, andmemories that may or may not operate in parallel.

Display Interface

Display interface 820 includes a monitor, LCD panel, or the like (notshown) coupled to a front panel of a housing surrounding system 10 orlocated remote from system 10. Display interface 820 displays the GUI,user prompts, user instructions and other information that may berelevant to a user.

User Control/Input Interface

User control/input interface 810 allows a user to navigate the GUI,provide commands, and respond to prompts or instructions provided to theuser. This can be a touch panel, keyboard, or mouse, for example. Inaddition, input interface 810 can be integrated into display interface820 such that the same device that displays prompts and the like is thesame device that allows a user to respond to said prompts.

Connections

As depicted in FIG. 20, modules 710, 720, 730, 740, 750 and 760 areconnected to computer control device via bus 801. More particularly,processor 804 of computer control device 802 operates each operabledevice within each module to output an action based on a processorinstruction 808 or to receive information. For example, with relation toI/O and post analysis module 710, computer control device 802 isconnected to first pick-and-place robot 410 a, elevator 100, and abarcode scanner (not shown). With regard to sampleconversion/preparation module 720, computer control device 802 isconnected to first and second decapper robots 450 a-b, pipetting robot480, clamp assembly 160, diluent dosing valves 176, primary andsecondary sample container stations 14, 150, and a barcode scanner (notshown). With regard to sample pre-preprocessing module 730, computercontrol device 802 is connected to second pick-and-place robot 410 b,barcode scanner 205, and bulk vortexers 220. With regard topreprocessing module 740, computer control device 802 is connected tothird pick-and-place robot 410 c, warmer 230 and cooler 290. With regardto shuttle processing module 750, computer control device 802 isconnected to rack handler assembly 240, barcode scanner (not shown), andshuttle transport assemblies 300 a-b. With regard to consumableaccumulation module 760, computer control device 802 is connected torack handler robot 320 and rack elevator 360. Computer control device802 may also be connected to other sensors distributed around system 10which may be used to locate and track items within system 10.

Methods of System Operation

As mentioned above system 10 has an I/O port 120 that receives allconsumables with the exception of bulk diluent containers 14 located instorage deck 22. System 10 identifies the consumables with limitedassistance of a user and then determines how the consumables are to behandled therein. In this regard, each consumable has a path throughsystem 10 which starts and ends at I/O port 120 and may include a detourto an analyzer. The following describes a method of operation of system10.

Generally

As depicted in FIG. 21, method 900 generally includes receiving 902consumables through I/O port 120 of I/O and post analysis module 710.The consumables are then sent to consumable accumulation module 760where they are accumulated 904 or queued in a first accumulation area 22for further operation.

Some of the consumables, such as pipette tips, controls, empty secondarycontainers, and certain primary containers are moved to samplepreparation/conversion module 720 where aliquots of samples aretransferred 906 from a primary container to a secondary container.

When sample preparation is completed and a secondary sample has beencreated, the secondary containers and controls are transported topre-preprocessing module 730 where they are accumulated 908 at a secondaccumulation area 210. The other consumables located within conversionmodule 720, such as the primary sample containers and empty racks, arereturned to consumable accumulation module 760 where they areaccumulated 908 within first accumulation area 22. These consumablesreturned back to first accumulation area 22 may be retrieved by a userand outputted from system 10 at any time. Also, if desired, primarysample containers can be returned to conversion module 720 from thefirst accumulation area 22 for extraction of another aliquot.

Some primary sample containers bypass 920 conversion 906 and are sentdirectly to pre-preprocessing module 730 from consumable accumulationmodule 760. These primary sample containers are accumulated 908 atsecond accumulation area 210 with the other containers that were sentthere from conversion module 720.

Once complete batches of primary and secondary sample containers andcontrols are accumulated at second accumulation area 210, or when a useractively or passively requests immediate preprocessing of incompletebatches, the batches are sent to preprocessing module 740 where thesamples/controls are preprocessed, such as pre-warmed and cooled. Thedevice is configured to provide a wide array of processing conditionswell known to one skilled in the art. Specific processing conditions arenot described herein. An active processing request can include the userinputting a real-time request into system 10 via user interface 810. Apassive processing request can include a preprogramed request toimmediately preprocess an incomplete batch when certain conditions aresatisfied. For example, a user may preprogram immediate preprocessing ofa batch, whether complete or incomplete, every Friday at 5:00 pm.Thereafter, the batches are sent to sample transfer module 750 wherethey are loaded into shuttles and distributed 924 to an analyzer.

Where preprocessing is not required, the batches bypass 926preprocessing 922 and are directed to shuttle processing module 750where they are loaded into shuttles 280 and distributed 924 to one ofone or more analyzers.

When analysis is completed, the used batches are retrieved 928 from theanalyzer and sent to I/O and post analysis module 710 where the usedsample containers are removed from shuttles 280, placed in racks 50,optionally sealed, and then transported to consumable accumulationmodule 760 where they are again accumulated 930 in first accumulationarea 22. The used batches of containers can be outputted 932 to a userfrom first accumulation area 22 upon request at any time.

Receipt/Input & First Accumulation

In a more particular description of method 900, consumables are received902 by system 10. Such consumables includes racks 30 carrying primaryfirst-type sample containers 01, racks 40 carrying primary second-typesample containers 02, racks 50 carrying primary third-type samplecontainers 03, racks 50 carrying third-type sample containers 03inoculated with controls, racks 50 carrying empty third-type containers03, and racks 182 carrying disposable pipette tips 489.

These racks are loaded into system 10 via I/O port 120 in any order theuser wishes. System 10 automatically determines the type of consumablesbeing loaded. In this regard, when a user loads rack 182 carryingdisposable pipette tips through I/O port 120 a barcode scanner (notshown) at I/O port 120 scans a barcode on rack 182. The associatedidentification number is recognized by system 10 as being associatedwith pipette tips. This ID number is then stored in memory 806 andtagged with a “pipette tip” tag within memory 806. This helps processor804 determine process flow for rack 182. Rack handler robot 320, asinstructed by the processor 804, traverses system 10 to I/O port 120 andremoves rack 182 from I/O port 120 via engagement arm 322. Rack handlerrobot 320 then carries rack 182 to first accumulation area 22 (rackstorage deck) and deposits rack 182 into a rack storage positiontherein. The coordinates of this rack storage position is tagged to therack's identification number within memory 806. This helps rack handlerrobot 320 later locate rack 182.

When user inputs a rack 30 containing primary first-type containers 01into I/O port 120, the barcode scanner at I/O port 120 scans a barcodeon rack 30. Processor 804 recognizes sample rack 30, via itsidentification numbers, as carrying containers that require conversionas first-type sample containers 01 are not compatible with an analyzer.The identification number of rack 30 is stored in memory 806 and taggedwith a “conversion required” tag. This helps processor 804 determineprocess flow for rack 30. Rack handler robot 320, as instructed by theprocessor 804, traverses system 10 to I/O port 120 and removes rack 30from I/O port 120 via engagement arm 322. Rack handler robot 320 thencarries rack 30 to first accumulation area 22 and deposits rack 30 intoa rack storage position. The coordinates of this rack storage positionare tagged to the rack's identification number within memory 806. A rack40 containing primary second-type containers 02 is handled in the samemanner as rack 30 as second-type containers 02 carried by rack 40 arealso not compatible with an analyzer. As such, a rack 40 input intosystem 10 through I/O port 120 is scanned, recognized as containingprimary second-type containers 02, tagged as “conversion required,” andstored within storage deck 22. Such tagging allows processor 804 todetermine the process flow for racks 30 and 40.

On the other hand, as mentioned above, rack 50 may include emptythird-type sample containers 03, primary third-type containers 03 withsample contained therein, or third-type sample containers 03 eachcontaining a control. In this regard, system 10 can automaticallydetermine which one of these loads is carried by rack 50 when input intosystem 10 or with the assistance of the user. For example, in oneembodiment, each rack 50 may have an identification number associatedwith the type of load. As such, a rack 50 containing empty containers 03may have an ID number recognizable by system 10 as such. The same wouldapply to racks 50 containing samples and controls. Alternatively, system10 can identify rack 50 at I/O port 120 via a scan of the rack itselfand then transport rack 50, once identified as a rack 50, to conversionmodule 720 or pre-preprocessing module 730 where a container 03 withinrack 50 is removed by a decapper robot or a pick-and-place robot andindividually scanned to further determine the type of load contained inrack 50. Thus, automatic identification of a rack 50 and its load canoccur via information extracted from the rack itself or a combination ofinformation from the rack and its individual containers.

In another embodiment, system 10 may have a default setting in whichsystem 10 defaults to the assumption that a rack 50 inserted through I/Oport 120 contains primary third-type containers 03 containing samplestherein. A user may override the default setting via user interface 810.For example, a user may load a rack 50 containing empty containers 03and may select an “empty container” option provided on user interface810 either just before inserting rack 50 into I/O port 120 orimmediately after, thereby overriding the default setting. In yetanother embodiment, a user may identify the type of load being carriedby a rack 50 for each rack 50 inputted into system 10.

Once rack 50 is scanned at I/O port 120 and its load determined, rackhandler robot 320 transports rack 50 to a rack storage position withinfirst accumulation area 22. The coordinates of this rack storageposition is tagged to the rack's identification number within memory806.

System 10 can be configured to handle dozens of the above describedracks. For example, system 10 can accumulate up to 36 racks in firstaccumulation area 22 by loading each rack through I/O port 120 asdescribed above. This allows a user to simply fill a rack with samplecontainers, controls, empty containers, or pipettes and input it intosystem 10. “Input mode” can be selected at the beginning of a workshift, for example, and each rack can be loaded until system 10 reachesfull capacity. The user can then walk away for the entire shift.However, “input mode” can be selected periodically throughout the day asneeded to load straggler samples or other consumables.

Once the above identified racks, particularly racks 30, 40, and 50, arereceived by system 10, they are placed in a queue for furtherpreparation and preprocessing. Generally, such racks and consumablestherein are placed in the queue in an order in which it was received bysystem 10. However, a user can identify a rack as being a “priority” inwhich the rack is moved up in the queue to be immediately prepared andpreprocessed. This may be performed by the user via user interface 810.

The system 10 has a processor 804 with logic that detects and respondsto errors in rack handling. The placement of a rack in the I/O port 120triggers a sensor that causes the pre-analytical system 10 to ask theoperator if the rack is empty or is carrying containers (empty orcontaining sample or reagents). The information provided by the operatoris forwarded to the rack manager. The containers in the rack are scannedand the scanned information is forwarded to the processor 804 managingthe operation of the pre-analytical system 10. The system data is readto determine if there is space for the rack.

If the rack is a tip rack 182, the tip rack's barcodes are read. If thebarcodes cannot be read the tip rack 182 is returned to the I/O port120. If the tip code is correct or the tip rack was not scanned, the tiprack is moved into the pre-analytical system if there is determined tobe room for the rack. If there is no room, the tip rack 182 is movedback to the I/O port 120.

The I/O port 120 has two sensors (not shown). A front sensor indicatesthat a rack (30, 40, 50, 182) has been placed in the port 120, and arear sensor determines if the rack has been placed far enough into theport 120 for further movement of the rack within the pre-analyticalsystem 10. If the back sensor does not detect a rack, an error messageresults and the operator is notified. The pre-analytical system 10determines if there is room for the rack. The rack robot 320 thenretrieves the rack from the I/O port 120 when the robot 320 is availableto do so. The rack robot 320 moves to the I/O port 120 to retrieve therack. If a motion error is detected, the rack robot 320 gets one retryat slow speed before module operation ceases and an operator isnotified. A rack stop in the I/O port 120 is disengaged prior to rackloading. If a motion error regarding the rack stop is detected, there isone retry before module operation ceases and an operator is notified.The rack handling robot 320 engages the sample rack and pulls it out ofI/O port 120 and onto carriage 350. If a motion error is detectedregarding this handoff, there is one retry before module operationceases and an operator is notified.

The status of the I/O port 120 presence sensors, the hotel sensors andthe rack handling robot sensors are evaluated and compared with a logictable. If the sensor readings are not consistent with the readingsassociated with further rack processing, an end module operation isstarted. If the sensor readings are consistent, then the rack handlingrobot 320 brings mover arm 322 to its home or intermediate position. Ifthe arm 322 will not move back to home, an error message results. Asample rack stop is engaged when the rack handling robot 320 is alignedwith the location in the rack storage area 22 in which the rack is to beplaced. If a motion error is detected, there is one retry at slowerspeed before module operation ceases and an operator is notified. Thesample rack is then positioned for unloading to the designated locationin the rack storage area 22. If a motion error is detected, then thereis one retry at slower speed before module operation ceases and anoperator is notified. Prior to unloading the rack in the rack storagearea 22, the rack storage area 22 is evaluated to determine if it isempty. If not empty, there is a failure and module operation ceases. Ifa rack position is empty, the rack robot 320 slides the rack into therack position in the rack storage area 22. If a motion error isdetected, there is one retry at slower speed before module operationceases and an operator is notified. Sensors are provided to verify thatthe rack was properly placed in the right location in the rack storagearea. If the sensors do not so indicate, the module operation ceases andthe operator is notified.

Sensors are provided to detect if rack mover arm 322 of the rack robot320 retracts to its intermediate/home position after disengaging fromthe rack. If the arm 322 does not retract, an error message is sent andthe module operation ceases. A rack inventory is then updated.

Similar operations and logic are provided in response to a command tomove a rack from the rack storage area 22 to the I/O port 120. If thereis a command, the system 10 interrogates the I/O sensors to check andsee if the I/O port 120 is occupied. The rack handling subsystem enterspause if there is a rack in the I/O port 120. If there is no rack in theI/O port 120, the system 10 determines if robot 320 is available. Ifnot, the system 10 waits. The rack robot 320, when available, thentravels to the rack position within storage area 22 to retrieve therack. If a motion error is detected, there is one retry at slower speedbefore module operation ceases and an operator is notified. The system10 verifies that the sensor feedback from the location in the rackstorage area 22 matches the rack inventory information. If the sensorindicates the position is empty, there is a failure that ends operationand an operator is notified. If the position is occupied, then thesample rack is engaged by the sample rack handler robot 320 as describedelsewhere herein. The rack storage sensors and front and back sensors onthe rack robot 320 will indicate whether or not the rack wassuccessfully transferred to the rack handling robot 320. Mover arm 322retracts with the rack connected thereto, but if it does not, amechanism failure is indicated. If arm 322 retracts properly to itsintermediate position, the robot 320 moves the rack to the I/O port 120where the sensors thereof cooperates to determine if the rack issuccessfully unloaded from the rack robot 320 to the I/O port 120. Onceplaced in the I/O port 120, the operator is alerted to remove the rack.

The system 10 also includes sensors and routines to identify errors thatoccur when a rack is transferred from on location in the rack storagearea 22 to another. As described above, sensors in the rack positions ofrack storage area 22 and on the rack handling robot 320 inform thesystem 10 of the presence (or absence) of racks in the specifiedlocations. Each movement is monitored for motion error. If motion erroroccurs, the motion is retried at a lower speed. If an error occursagain, the module operation is terminated and an operator informed. Asnoted above, when the rack is moved from one position to another, therack inventory is updated with the new information.

Conversion

Once racks are loaded into first accumulation area, system 10 beginspreparing and preprocessing samples. This includes sample conversion906. With regard to conversion 906, rack handler robot 320, asinstructed by processor 804, removes a pipette tip rack 182 from itsrack storage position and places it on first pre-analytical processingdeck 24 at space 180. Rack handler robot 320 also automatically removesa rack 50 containing controls from its rack storage position and placesit at rack space 114/116. Similarly, rack handler robot 320 removes rack50 containing empty third-type containers 03 from its rack storageposition and places it at third rack space 114/116. Also, rack handlerrobot 320 removes a rack 30 from its rack storage position and places iton first pre-analytical processing deck 24 at second rack space 112.Although, it should be understood, that a rack 40 or a rack 50 withcontainers having previously penetrated caps may also be placed atsecond rack space 112 for conversion.

Thereafter, first decapper robot 450 a, as instructed by processor 804,grips a primary first-type container 01, lifts it from rack 30 andplaces it in front of a barcode scanner (not shown) within conversionmodule 720 such that a barcode located on container 01 is read. Thisbarcode notifies processor 804 of the assay to be performed on thesample located within container 01 which is stored in memory 806.Decapper 450 a then deposits container 01 into receptacle 142 at primarysample container station 140. Processor 804 may then operate a motorwithin motorized base 144 to vortex container and re-suspend sample.Whether or not container 01 is vortexed may depend on the assay to beperformed. In addition, vortexing conditions (e.g. duration and speed)may vary depending on the container type and assay to be performed. Suchdeterminations are made by processor 804. Decapper 450 a re-grips andde-caps container 01 (best shown in FIG. 8A).

Similarly, second decapper robot 450 b, as instructed by processor 804,grips an empty third-type container 03 within rack 50, lifts it fromrack 50, and places it in front of the barcode scanner within conversionmodule 720 such that a barcode located on container 03 is read.Processor 804 then associates the identification number of primaryfirst-type container 01 with empty third-type container 03 whichincludes associating the assay to be performed with container 03.Decapper 450 b deposits empty third-type container 03 into receptacle152 within secondary sample container station 150. Decapper 450 bde-caps container 01. At this point, opened third-type container 03 isdisposed beneath spout 174 of diluent dispenser 170. Based on the assayto be performed, processor 804 operates a dosing pump 176 on a channel175 of a select bulk diluent container 14 which contains a diluent thatis suitable for the particular assay to be performed. A controlled doseof the diluent is dispensed from the select channel 175 into third-typecontainer 03.

Thereafter, pipetting robot 480 retrieves a disposable pipette tip 489from rack 182 and aspirates an aliquot from primary first-type container01 at primary sample container station 140. Pipetting robot 480 thendispenses the aliquot into third-type container 03 which is nowsecondary third-type container 03. Decapper 450 b recaps container 03and processor 804 operates a motor within motorized base 154 atsecondary station 150 to vortex secondary third-type container 03 to mixdiluent with sample and suspend particulates therein.

Primary first-type container 01 is recapped by decapper robot 450 a andtransferred back to rack 30 at space 112. Also, secondary third-typecontainer 03 is transferred from secondary sample container station 150back to rack 50 at space 114/116 via decapper 450 b. Periodicallydecapper 450 b grips a third-type container 03 containing a control andremoves it from rack 50 at space 114/116. The control is placed bydecapper into rack 50 at space 114.

Conversion 906 is repeated with other containers in racks 30 and 50until rack 50 at space 114 is filled with secondary third-typecontainers. Since rack 30 carries less containers than rack 50,additional racks 30, 40 or 50 may be moved to rack space 112 as neededto continue filling rack 50 with secondary sample containers.

If a container cannot be de-capped, processor 804 instructs decapperrobot 450 b to place container 03 back into rack 50 at space 114. Anyfurther de-cap failures are arranged in a right-to-left or left-to-rightarrangement along consecutive rows beginning with a front row or rack50. Processor 804 alerts a user via display interface 820, who can thenrecall rack 50. The arrangement of de-cap failures allows the user toeasily identify the defective containers for troubleshooting once rack50 is output from system 10.

If the third-type sample container 03 cannot be recapped, the uncappedsample is held over a drip tray. The sample container from which theprimary sample for preparation was obtained is recapped and placed backinto the input rack (30 or 40). The system 10 enters a pause state whena rack is stuck. Under such a pause state, the rack is placed in apenalty box; all sample conversions in the process are completed afterwhich the conversion robots all retreat to their home positions.

Second Accumulation

Subsequent to sample conversion 906, secondary third-type containers 03are sent back to first accumulation area 22 where they are queued forfurther processing and then sent to second accumulation area 210.Alternatively, secondary third-type containers 03, once conversion 906is completed, are sent directly to second accumulation area 210 fromconversion module 720. In this regard, when rack 50 is filled withsecondary third-type containers 03 (and controls), rack handler robot320 removes rack 50 from space 114 and hands it off to rack elevator360. When received by rack elevator 360, processor 804 operates elevator360 such that rack 50 is moved upward into pre-preprocessing module 730at space 200. At this location, second-pick and place robot 310 bremoves the secondary third-type containers 03 (and controls) from rack50 individually and places them in view of barcode scanner 205 whichidentifies the assay to be performed on the sample therein.Pick-and-place robot 310 b then places these containers 03 into secondaccumulation area 210 in groups or batches of the same assay order. Forexample, sample containers 03 containing samples that require an entericbacterial assay may be grouped with like containers, while othercontainers 03 containing samples requiring a Group B streptococcus assaymay be grouped together into a separate batch. This allows samplecontainers 03 trickling in from other racks 50 to be batched togetherfor subsequent movement to an analyzer. Although, like containers can begrouped together in batches, like containers can also be placed apartwithin second accumulation 210 such that containers designated fordifferent assays can be disposed therebetween as computing system 800knows where each container within a batch is located and can retrievethem accordingly when a sufficient batch is accumulated.

If a container's barcode cannot be read, processor 804 instructspick-and-place robot 310 b to place container 03 back into rack 50 atspace 200. Any further barcode scan failures are arranged in aright-to-left or left-to-right arrangement along consecutive rowsbeginning with a front row or rack 50. Processor 804 alerts a user viadisplay interface 820, who can then recall rack 50. The arrangement ofbarcode scan failures allows the user to easily identify the defectivecontainers for troubleshooting once rack 50 is output from system 10.

In addition to accumulating secondary third-type containers 03 at secondaccumulation area 210 subsequent to conversion 906, other consumablesutilized in the conversion process 906 are again accumulated in thefirst accumulation area 22. This may occur when their supply isexhausted or prior to such exhaustion. More particularly, when a pipettetip rack 182 is depleted of disposable pipette tips 489, rack handlerrobot 320 removes rack 182 from rack space 180 and deposits it in a rackstorage position at first accumulation area 22. Similarly when a rack 50is depleted of controls, rack handler robot 320 removes rack 50 fromrack space 114/116 and deposits it in a rack storage position at firstaccumulation area 22. These empty racks 50 and 182 may be removed 910from first accumulation area and outputted 932 to a user at any time atthe user's request.

In addition, when an aliquot has been taken from each container 01 (or02) of rack 30 (or 40), rack handler robot 320 removes rack 30 from rackspace 112 and deposits it in a rack storage position at firstaccumulation area 22. From there, rack 30 may be redirected 907 toconversion module 720 via rack handler robot 320 for removal of anotheraliquot from one or more of its containers for further analysis. Rack 30may also be removed 910 from first accumulation area 22 and outputted932 to a user at the user's request.

While many of the consumables loaded into system 10 pass throughconversion module 720, certain containers bypass 920 sample conversion906 and are sent to be further accumulated 908. In particular, primarythird-type containers 03 can bypass 920 conversion 906 as thesecontainers 03 are suitable for an analyzer and, therefore, do notrequire conversion. In this regards, rack handler 320, as instructed byprocessor 804, removes a rack 50 containing primary third-typecontainers 03 from its rack storage position in first accumulation area22. Rack handler 320 bypasses conversion module 720 and takes rack 50directly to rack elevator 360. Rack 50 is handed off to rack elevator360. When received by rack elevator 360, processor 804 operates elevator360 such that rack 50 is moved upward into pre-preprocessing module 730at space 200. At this location, second pick-and-place robot 410 bremoves primary third-type containers 03 from rack 50 individually andplaces them in view of barcode scanner 205 which identifies the assay tobe performed on the samples contained therein. Pick-and-place robot 410b then places these containers 03 into second accumulation area 210 ingroups or batches of the same assay. Barcode scan failures are againplaced back into rack 50 in a predefined order. When rack 50 is emptiedor only contains barcode failures, it is moved by rack elevator 360 andrack handler so as to place rack 50 back into first accumulation area22.

Thus, as described above, second accumulation area 210 can includeprimary third-type containers 03, secondary third-type containers 03,and third-type containers 03 containing controls which are distributedamong the accumulated batches.

Preprocessing

With batches of containers 03 accumulating at batch-accumulation area210, complete batches are sent for preprocessing 922 and/or distribution924 to an analyzer. In this regard, processor 804 keeps track of batchsize and when a batch size matches a batch capacity of a designatedanalyzer, processor 804 instructs second pick-and-place robot 410 b toload a batch of containers 03 into bulk vortexers 220. Processor 804operates vortexers 220 which is provided to re-suspend the samples.

If the samples contained within containers 03 of the batch requirepreprocessing 922, third pick-and-place robot 410 c, as instructed byprocessor 804, removes each third-type container 03 from bulk vortexers220 and individually places them into receptacles 234 of warmer 230.When these containers 03 were barcode scanned by scanner 205,information regarding preprocessing was associated with each container'sidentification number within memory 806. Such information may includewarming time, warming temperature, and cooling time. For example, abatch of containers 03 may require samples to be heated to about 100 to115 degrees Celsius for about 9 to 17 minutes. Processor 804 operateswarmer 230 at a processor determined set-point to achieve the designatedheating conditions. When the allotted time period has elapsed,containers 03 of the batch are removed in the order they were placedinto warmer 230 by third pick-and-place robot 410 c and moved to cooler290. Processor 804 operates fans 296 to convectively cool the batch ofsample containers 03 for a time period which may vary depending on thecontainer type and assay to be performed.

If the samples with containers 03 of the batch do not requirepreprocessing 922, they are removed from bulk vortexers 220 orbatch-accumulation area 210 by third pick-and-place robot 410 c andtransferred to shuttle processing module 750 thereby bypassingpreprocessing 922.

Distribution

Once a batch has completed preprocessing 922 or bypasses preprocessing922, the batch is picked by third pick-and-place robot 410 c from anylocation within operating envelope 610 c and placed into a receptacle283 of a shuttle 280 docked at one of first or second docking stations260 a-b. Each shuttle 280 may have fewer receptacles 283 than an entirebatch. Thus, pick-and-place robot 410 c may load multiple shuttles 280for a single batch. For example, shuttles 280 may include 12 receptacles283 and a batch may comprise 24 third-type containers 03. As such, inthis example, two shuttles 280 are filled for the batch.

Once the one or more shuttles 280 are filled, transfer arm assembly 270picks up a shuttle 280 from docking station 260 a or 260 b and drivesshuttle 280 past a barcode scanner (not shown) located within shuttleprocessing module 750 which scans a barcode on shuttle 280. Processor804 links or otherwise associates the shuttle's identification numberwith those of containers 03 disposed therein which helps track thelocation of containers 03.

Processor 804 also recalls information regarding the assay to beperformed and determines, based on analyzer information that is storedon memory 806, which analyzer coupled to system 10 is suitable toperform the particular assay. For example, a first analyzer 830 coupledto a right side of system 10 may perform a first assay, such as aGonorrhea assay, while a second analyzer 840 coupled to a left side ofsystem 10 may perform a second assay, such as an HPV assay. If the batchrequires the first assay, then processor 804 chooses first analyzer 830and operates transfer arm 270 so that transfer arm 270 places shuttle280 onto first shuttle transport assembly 300 a. First transportassembly 300 a is then operated to transport shuttle 280 to firstanalyzer 830. Conversely, if the batch requires the second assay, thenprocessor 804 chooses second analyzer 840 and operates transfer arm 270so that transfer arm 270 places shuttle 280 onto second shuttletransport assembly 300 b. Second transport assembly 300 b is thenoperated to transport shuttle to first analyzer 830. If a batch is largeenough to fill multiple shuttles 280, transfer arm assembly 270 movesthe remaining shuttles 280 to the designated transport assembly 300 a or300 b which distributes those shuttles 280 to the appropriate analyzer830 or 840. Processor 804 communicates with the designated analyzer tonotify the analyzer so that it is prepared to receive shuttle 280. Thisworkflow is illustrated in FIG. 22C. As noted above and in theillustrated workflow, when the shuttle returns with the samplecontainers carrying the remaining portion of the sample. If the samplecontainers are to be sent to an analyzer for a second test, they mayremain in the shuttle while sample containers carrying samples notdesignated for a second analyzer are unloaded. If there are emptyreceptacles in the shuttle designated to carry the batch to the secondanalyzer, additional sample containers designated for the secondanalyzer can be added.

Retrieval

When analysis is completed shuttle 280 and the sample containers 03disposed therein is retrieved from analyzer 830 or 840. In this regard,the analyzer communicates with processor 804 notifying system 10 thatshuttles 280 are being sent back to system 10 and also identifies any ofcontainers 03 that were incapable of completing the assay, such as apenetrable cap failing to be punctured. This information is stored inmemory 806 by processor 804 and associated with the particularcontainer's identification number. Shuttle 280 is then transported alongtransport assembly 300 a or 300 b until it reaches shuttle handlingassembly 240. Transfer arm 270, as instructed by processor 804,retrieves shuttle 280 from the appropriate transport assembly and placesshuttle 280 on third docking station 260 c.

Referring to FIG. 18, when the accession number of sample is read andthe pre-analytical system computing device 1350, on instructions fromthe workflow computing device 1330 has the accession number associatedwith two or more tests associated with two or more analyzers, the sampleis prepared and sent to the first analyzer as described herein. When thesample is returned, the sample container is removed from the shuttle 280[ELSEWHERE YOU STATE THAT THE SAMPLE CAN REMAIN IN THE SHUTTLE IF STI+ISORDERED] and placed in a rack. The sample barcode is read and the sampleis associated with the rack in which it is placed. When the rack is full[IS THE RACK LOADED RANDOMLY; HOW

Third Accumulation

At this point, the used third-type containers 03, which may have apunctured cap, are accumulated 930 back in first accumulation area 22.In this regard, an empty or partially empty rack 50 is moved from firstaccumulation area 22 by rack handler robot 320 and delivered to firstrack space 110 on first pre-analytical processing deck 24. Firstpick-and-place robot 410 a, as instructed by processor 804, removes eachused third-type container 03 from shuttle 280 and places them in frontof a barcode scanner (not shown) located at I/O and post analysis module710 to identify the container 03. If the container 03 is identified asnot capable of being analyzed, such container 03 and other containerslike it are filled in receptacle rows of rack 50 from front-to-back. Ifthe container 03 is identified as being analyzed by analyzer, thenpick-and-place robot places such container 03 and other containers likeit in receptacles rows of rack 50 from back-to-front. This allowscontainers that could not be analyzed to be grouped in an easilyidentifiable location so that a user can quickly locate the failedcontainers and troubleshoot the issue.

Once rack 50 is filled at space 110 or close to being filled, elevator100 optionally seals the punctured containers. Alternatively, eachpunctured container may be sealed prior to being placed into rack 50.Thereafter, rack handler 320 removes rack 50 from space 110 and moves itto a rack storage position within first accumulation area 22.

Output

Rack 50 with used containers 03 remains in first accumulation area 22until a user requests its output 932. In this regard, a user may putsystem 10 into “unload mode” via user control interface 810 whichmarshals assistance from rack handler robot 320. Processor 804 asks theuser via display interface 820 what item the user desires to haveunloaded and may provide a predefined list of items to be removed or mayprovide a search bar that may allow user to query a patient's name orsome other identifier tagged in system 10 in association with the item'sidentification number. When selected by the user, rack handler robot 320removes a designated rack that may be the item of interest or maycontain the item of interest and delivers it to I/O port 120 where theuser removes it from system 10.

This method 800 including the accumulation steps of such method providesseveral benefits. One such benefit is that accumulation creates storesof consumables that can be continuously drawn upon which minimizesdowntime as there is frequently a rack or container waiting in a queuefor a next step. Another benefit is that accumulation allows a user toprovide a large volume of consumables into system 10 which allows theuser to walk away for a significant amount of time. A further benefit ofaccumulation as described is that it allows system 10 to be both a batchprocessor and random access system. More particularly, sample containers03 that are prepared for analysis are accumulated in batchescorresponding to an analyzer's capacity which maximizes analyzer output.In addition, sample containers that are not on first or secondpre-analytical processing decks or in an analyzer are accumulated instorage deck 22. This allows a user to randomly output a samplecontainer. Moreover, a user can sporadically input sample containers,pipette tips, and other consumables as desired.

As noted elsewhere herein, each process and sub-process within system 10has an error handling routine to ascertain and address errors inhandling and processing. The error handling routines described hereinare for moving individual tubes from a rack, reading the rackinformation, removing individual sample containers from the rack andreading the container information by spinning the container in front ofa bar code scanner.

Each motion of the pick-and-place robots 410 a-c and decapper robots 450a-b described herein are monitored. Motion errors are addressed by oneretry at slower speed, after which operation is halted and an error inoperation is communicated to an operator.

Each subsystem/apparatus/piece of equipment in the larger pre-processingsystem 10 described herein also has its own power recovery protocol. Forexample, rack handling robot 320, pre-processing bar code reader,shuttle handling robot 240, vortexer 220, warmer 230 and cooler 290 allhave preprogrammed power recovery protocols when power is restored tothe system 10. All also have sensors that detect motion errors and arein communication with a processer/controller that will retry, at halfspeed in some embodiment, the motion. If the motion error persists, theerror is reported and, depending upon the criticality of thesub-system/apparatus/device, the analyzer or specificsubsystem/apparatus/device may be paused or shut down completely untilthe error is corrected. Such protocols are described as diagnosticself-test herein. The warmers 230 and coolers 290 are also subjected todiagnostic self-test to ensure proper operation of the heating andcooling elements with real time data checks. For example, the fan units296 used in the cooler 290 has a tachometer that monitors fan speed. Thesystem 10 will put an operator on notice if fan speed is outside apredetermined range.

Alternatives Single Tube Transport

Numerous variations, additions and combinations of the featuresdiscussed above can be utilized without departing from the presentinvention. For example, it was described above that an aliquot istransferred from a primary container to a secondary container and thatsuch secondary container is placed into a rack 50. Once rack 50 isfilled or partially filled with secondary containers, it is transportedto second pre-analytical processing deck 26 from conversion module 720via rack handler robot 320 and rack elevator 360 where each samplecontainer 03 is removed therefrom. FIG. 23 depicts a single containertransport 1000 that can be optionally included in a system 10′ totransport secondary third-type containers 03 from conversion module 720to the second pre-analytical processing deck 26 in lieu of transportingan entire rack 50 filled with secondary containers 03.

Single container transport 1000 generally includes a horizontal rail1010, vertical rail 1002, carriage 1020, cup 1006 and a motor. The motoris a magnetic linear motor comprised of a power source 1016, stator 1014and mover 1022. However, in some embodiments, the motor can be arotating electric motor coupled to a rack and pinion mechanism.

Horizontal rail 1010 includes a base 1012 and the stator 1014. Stator1014 is connected to base 1012 such that it extends along a lengththereof. Elongate slots 1013 also extend along the length of base 1012at opposite sides thereof. Power source 1016 is connected to one end ofbase 1012 and energizes stator 1022.

Carriage 1020 is a U-shaped structure that includes engagement members(not shown) extending from sideways facing inner surfaces and mover 1022which is attached to a downwardly facing inner surface. Carriage 1020connects to horizontal rail 1010 such that mover 1022 is positioneddirectly above stator 1014 and the engagement members engage elongateslots 1013.

Vertical rail 1004 is connected to an outer surface of carriage 1020 atone end of vertical rail 1002 such that a portion of vertical rail 1002hangs lower than carriage 1020 and horizontal rail 1010. Cup 1006 has areceptacle sized to receive a single container 03 therein and isslidably connected to vertical rail 1004. However, it is contemplatedthat an array of more than one cup can be attached to vertical rail 1004to transport more than a single container 03 in a single trip. In oneembodiment, cup 1006 can be raised or lowered along vertical rail 1004via a motor (not shown) mounted to carriage 1020. In another embodiment,single container transport 360 may interact with rack elevator 360 toraise cup 1006 along rail 1004.

Single container transport can be connected to a support component 21 ata left-end of system 10 such that horizontal rail 1010 extends in afront-back direction.

In a method of operation, when a primary sample is obtained from aprimary first-type or second-type container 01, 02 and transferred to asecondary third-type container 03 to prepared a secondary sample, thesecondary container 03 is moved by decapper robot 450 b from secondarycontainer station 150 and into cup 1006. At this point, cup 1006 ispositioned near a bottom-end of vertical rail 1004 and a front-end ofhorizontal rail 1004. Power source 1016 then energizes stator 1014 whichmoves carriage 1020 toward the back of system 10. Either concurrentlywith or sequentially to carriage movement, cup 1006 is moved upwardlyalong vertical rail 1004 until it reaches an upper extent thereof. Oncecarriage 1020 reaches a back-end of horizontal rail 1010, the motorstops carriage 1020. At this point, container 03 is within reach ofpick-and-place robot 410 c, which then reaches down and removescontainer 03 from cup 1006 and moves it to batch-accumulation area 210.

Thereafter, mover 1022 and stator 1014 drives carriage 1020 toward thefront of system 10 and cup 1006 is lowered toward a bottom extent ofvertical rail 1004 so that cup 1006 can be filled with another secondarythird-type container 03. This sequence is repeated as required tosupport the desired workflow.

Although, single container transport 1000 can be included in system 10′to move secondary containers to second pre-analytical processing deck24, rack handler robot 320 can be utilized to transport primarythird-type containers 03 to rack elevator while single containertransport transfers secondary third-type containers 03 to the back.

Sample Container Retention Assembly

FIGS. 24A-24D depicts sample container retention assembly 1100 which isanother feature that can be added to system 10. Sample containers 03 mayeach include a penetrable cap 08 (see FIG. 24C) which is penetrated byan analyzer in order to retrieve a sample therefrom. This can cause apipette tip or needle to become stuck in the penetrable cap of thesample container 03. As the tip or needle is withdrawn from container03, the container can be carried by the tip or needle, potentiallyspilling the contents of the container 03 or removing the container 03from the workflow, causing loss of sample or contamination issues orboth. To secure the sample containers as the pipette needle is withdrawntherefrom, sample container retention assembly 1100 can be coupled to anend of shuttle transport assembly 300 a and/or 300 b, which may bedisposed within or near a target analyzer, and used to retain samplecontainers 03 within a shuttle 280 as a pipette or needle is removedtherefrom. This helps prevent sample containers 03 from beinginadvertently removed from a shuttle 280 and its contents spilled aftersample aspiration or dispense.

Sample container retention assembly 1100 generally includes a shuttletransport assembly 1110, clamping assembly 1150, and a motor assembly1140. The shuttle transport assembly can be any conveyor assembly, suchas embodiment 1110 depicted in FIGS. 24A-24D or shuttle transportassembly 300 described above in relation to FIG. 13.

Shuttle transport assembly 1110, as depicted, generally includes anelongate conveyor platform 1112 or track. In some embodiments, conveyorplatform 1112 can be incorporated into an analyzer and placed adjacentto an end of shuttle transport assembly 300 a and/or 300 b such that asmall gap is formed therebetween. In other embodiments, conveyorplatform 1112 may span both an analyzer and system 10 such that conveyorplatform extends between the two. In even further embodiments, conveyorplatform 1112 may only be disposed in system 10. Conveyor platform 1112includes top and bottom surfaces and side surfaces 1114. A conveyor belt1116 is wrapped about the top and bottom surfaces and coupled to a beltand pulley mechanism 1118 which moves conveyor belt 1116 relative to thetop and bottom surfaces.

Shuttle transport assembly 1110 also includes a backstop 1120 which iscomprised of an arm 1122 and bumper and/or position arm. Arm 1122 isattached at a first end thereof to a side surface 1114 of conveyorplatform 1112 and is generally curved or angled so that a second end ofarm 1122 is positioned over conveyor belt 1116. The bumper includes abumper portion 1126 and a threaded extension 1124 (see FIG. 24B)extending from bumper portion 1126. The bumper is threadedly engaged tothe second end of arm 1122 via threaded extension 1124 such that theposition of bumper portion 1126 relative to arm 1122 is adjustable byrotating the bumper in a first or second direction. Such adjustmentmoves bumper portion 1126 in a direction parallel to a direction ofconveyor belt movement and helps properly align shuttle 280 whendisposed on conveyor belt 1116.

A first and second guiderail 1130 a-b extends from corresponding sidesurfaces 1114 of conveyor platform 1112 such that longitudinal portions1132 a-b thereof are spaced a distance slightly larger than a width ofshuttle 280. Guiderails 1130, when attached to conveyor platform 1112,each define an opening 1134 a-b that extends from conveyor platform 1112to a bottom surface 1134 of longitudinal portions 1132 a-b (best shownin FIGS. 24A & 24D). These openings 1134 a-b are sufficiently large asto expose transverse openings 286 of a shuttle 280 when positioned onconveyor belt 1116 and abutting backstop 1120.

Motor assembly includes a motor 1141, gearbox 1142, and drive shaft1148. Motor 1141 is connected to conveyor platform 1112, such as to sidesurfaces 1114, so that it hangs beneath the platform's bottom surfacewithout interfering with the movement of conveyor belt 1116 and suchthat an output shaft extending from gearbox 1142 extends in a directionparallel to a length of conveyor platform 1112. Motor 1141 can be anyrotating electric motor capable of operating in two directions. Gearboxmay be configured to reduce output speeds and increase output torque ofoutput shaft 1143 relative to motor 1141.

A drive shaft 1148 is coupled at one end thereof to shaft 1143 via acoaxial coupling 1146. Another end of drive shaft 1148 remote from motor1141 is coupled to a bearing connected to shuttle transport assembly1110 to help support drive shaft 1148 while allowing rotation thereof.Drive shaft 1148 includes a pair of flanges 1145 a-b connected theretoand extending radially outwardly. Flanges 1145 a-b are offset from eachother and rotatable in conjunction with drive shaft 1148 and areconfigured for connection to clamping assembly 1150, such as by havingopenings for receipt of pins.

Clamping assembly 1150 includes a leverage block 1150 and two armassemblies 1160, 1170. First arm assembly 1160 includes a pair of drivenmembers 1162 a-b and a pair of intermediate members 1164 a-b. Inaddition, first arm assembly 1160 includes an engagement member 1166.

Driven members 1162 a-b are bar-linkages that each have a first andsecond end and a length extending therebetween. Similarly, intermediatemembers 1164 a-b are bar-linkages that each have a first and second endand a length extending therebetween.

Engagement member 1166 has a first and second end and a length extendingtherebetween. In addition, engagement member 1166 has a width orthogonalto its length (see FIG. 24C). The length of engagement member 1166 isabout the same as the length of shuttle 280.

Engagement member 1166 also includes an array of pointed members 1169extending from a side surface thereof at an oblique angle relative tothe width of engagement member 1179. The number of pointed members 1169corresponds to a number of receptacles in a row of shuttle 280. Forexample, as shown in FIGS. 24A and 24C, shuttle 280 includes a first row281 of six receptacles 283. As such, the depicted engagement member 1166includes six pointed members 1169. Each pointed member 1169 is separatedfrom an adjacent pointed member 1169 a distance substantially equal to adistance separating transverse slots 286 of shuttle 280. In addition,each pointed member 1169 has a length and cross-sectional dimensionsufficient to pass through transverse slots 286 and pressure contact orotherwise engage a bottom portion of a container 03 disposed within ashuttle 280. A pointed end of each pointed member 1169 is sufficientlysharp to indent, and in some cases even puncture, a bottom of acontainer 03 in order to secure the containers in the shuttle as thepipette tip is withdrawn therefrom. However, as shown in FIG. 24C,containers 03 preferably have a cylindrical skirt 07 disposed at thebottom portion so that puncturing such skirt 07 does not puncture theportion of the container in which the sample is disposed.

Leverage block 1152 is generally a rectangular block with a rectangularrecess 1154 extending along a length thereof. This rectangular recess1154 has a width slightly larger than a width of conveyor platform 1112and defines opposing extensions 1156, 1157 which are each attached toside surfaces of conveyor platform 1112 such that leverage block isgenerally disposed beneath conveyor platform 1112 and spans conveyorplatform 1112 from side-to-side. Rectangular recess 1154 forms a spacefor conveyor belt 1116 to operate unimpeded.

The first ends of driven members 1162 a-b are each rotatably connectedto a corresponding flange 1145 a-b of driven shaft 1148. Intermediatemembers 1164 a-b are each rotatably connected at a first end thereof tothe second end of corresponding driven members 1162 a-b. Intermediatemembers 1164 a-b extend upwardly at an angle relative to driven members1162 a-b and are each rotatably connected to opposite ends of leverageblock extension 1156. This connection may be made by inserting a pin orother fastener through each intermediate member 1164 a-b between theirfirst and second ends and into leverage block 1152. In addition,intermediate members 1164 a-b are fixedly connected at the second endthereof to opposite ends of engagement member 1166. Engagement member1116 spans a distance between intermediate members 1164 a-b and itslength is generally orthogonal to the lengths of intermediate members1164 a-b. The width of engagement member 1166 also extends generallyorthogonally relative to a length of intermediate members 1164 a-b suchthat pointed members 1169 are angled downwardly toward conveyor belt1116 (best shown in FIGS. 24C and 24D).

Second arm assembly 1170 is substantially the same as first arm assembly1160 and is coupled to drive shaft 1148 and leverage block 1152 in thesame manner as first arm assembly 1160 described above. In particular,second arm assembly 1170 includes a pair of driven members 1172 a-b, apair of intermediate members 1174 a-b, and an engagement member 1176that includes an array of pointed members 1179 that match a number ofreceptacles 283 within a second row 282 of shuttle 280. Driven members1172 a-b are pivotally connected to corresponding flanges 1145 a-b atpositions opposite driven members 1162 a-b of first arm assembly 1160.For example, ends of driven members 1172 a-b are connected at a positionsubstantially 180 degrees about flanges 1145 a-b from a connectionposition of driven members 1162 a-b.

When arms 1160, 1170 are connected to leverage block 1152 and driveshaft 1148, arms 1160, 1170 generally have two positions. The firstposition being a release position, and the second position being anengagement position. In the release position (shown in FIG. 24C) driveshaft 1148 is rotated such that the first ends of the driven members1162 a-b are positioned above the first ends of the driven members 1172a-b. Also, in this position, the angle formed between driven arm members1162 a-b and intermediate members 1164 a-b of first arm assembly 1160 isacute, while the angle formed between driven arm members 1172 a-b andintermediate members 1174 a-b of second arm assembly 1170 is obtuse.However, it should be understood that the opposite configuration canalso constitute a release position in which driven ends 1172 a-b arepositioned above driven ends 1162 a-b and the angles formed withintermediate members 1174 a-b and 1164 a-b are acute and obtuse,respectively. In this release position, engagement members 1166, 1176are pushed outwardly away from platform 1112 so as to allow shuttle 280to travel down conveyor belt 1116 and contact backstop 1120.

In the engagement position (shown in FIG. 24D), drive shaft 1148 isrotated such that the first ends of the driven members 1162 a-b and 1172a-b are aligned in a horizontal plane. Also, intermediate members 1164a-b and 1174 a-b, in this position, are generally perpendicular relativeto drive members 1162 a-b and 1174 a-b, respectively. In this position,engagement members 1166, 1176 are pushed inwardly toward platform 1112such that the widths of engagement members 1166, 1176 are substantiallyhorizontal and pointed members 1169, 1179 extend through openings 1134a-b of guiderails 1132 a-b, respectively, and transverse slots 286 ofshuttle 280 when disposed on conveyor 1116.

In a method of sample container retention, a shuttle 280 with containers03 disposed therein is placed on shuttle transport assembly 1110, suchas by shuttle handling assembly 240. Belt and pulley mechanism 1118 isoperated to move conveyor belt 1116 and shuttle 280 from one end ofshuttle transport assembly 1110 to another. Shuttle 280 contactsbackstop 1120 and belt 1116 is turned off such that shuttle 280 remainsin contact with backstop 1120.

At this point, clamping assembly 1150 is in the release position, asdescribed above. Motor 1141 is then turned on and rotates drive shaft1148 in a first direction. This causes the first ends of driven members1162 a-b of first arm assembly 1160 to be driven from about a 90 degreeposition (relative to a horizontal plane bisecting shaft 1148) to a zerodegree position, and the first ends of driven members 1172 a-b of secondarm assembly 1160 to be driven from about a 270 degree position to a 180degree position (see FIGS. 24C and 24D for contrast). As this occurs,intermediate members 1164 a-b and 1174 a-b are rotated inwardly bydriven members 1162 a-b and 1172 a-b, respectively, toward platform 1112and a vertical orientation. Pointed members 1169, 1179 then pass throughtransverse openings 286 of shuttle 280 and contact skirt 07 ofcontainers 03 disposed therein. Motor 1141 can be operated to furtherdrive pointed members 1169, 1179 into containers 03 so that pointedmembers 1169, 1179 press into skirt 07 of containers 03.

As shown in FIG. 24D, pointed members 1169, 1179 contact and grip eachcontainer 03 from only one side of container 03. Shuttle 280 itself andthe opposing, but nearly identical, pressure applied by arm assemblies1160, 1170 prevent containers 03 from moving while pointed members 1169,1179 bite into them. This allows pointed members 1169, 1179 to indent orpierce the container's skirt 03 in order to prevent the container frommoving vertically out of shuttle 280 during sample aspiration.

Once containers 03 are sufficiently restrained, system 10 communicatesto an analyzer that the samples are ready for aspiration or dispense. Apipette (not shown) located in the analyzer pierces caps 08 of samplecontainers 03 to remove sample therefrom for diagnostic testing or addreagents thereto for sample processing. The pipette may reach intosystem 10 to access containers 03. Alternatively, and preferably, clampassembly 1150 and end of shuttle transport assembly 1110 are disposedwithin the analyzer and the pipette accesses containers 03 within theanalyzer. As the pipette withdraws from containers 03 after aspirationor dispense, the pipette drags along the cap's seal 09. Any tendency ofthe pipette to carry the container along with it is opposed by clampingassembly 1150, thereby securing container 03 in the shuttle 280 duringwithdrawal of the pipette.

Once the analyzer has completed sample removal, the analyzercommunicates with system 10 that shuttle 280 is ready for transport backinto system 10. Thereafter, motor 1141 turns drive shaft 1148 in asecond direction (or again in the first direction). This causes the endsof driven members 1162 a-b of first arm assembly 1160 to return to the90 degree position and the ends of driven members 1174 a-b of second armassembly 1170 to return to the 270 degree position. Intermediate members1164 a-b and 1174 a-b are driven outwardly away from platform 1112 andengagement members 1150 are disengaged from containers 03. Conveyor belt1116 is then operated and shuttle 280 moves toward shuttle handlingassembly 240.

Alternative Tip Ejector

FIGS. 25A-25D depict an alternative pipette head 1200. Pipette head 1200is similar to pipette head 500 in that it includes a main board 1201 andpipette assembly 1202. However, pipette head 1200 differs in thatpipette head 1200 has an integrated z-axis drive mechanism. In otherwords, the z-axis drive mechanism of pipette head 1200 couples mainboard 1201 to pipette assembly 1202 whereas the z-axis drive mechanismof robot 480 couples pipette head 500, via main board 501, to pipettearm 481. The z-axis drive mechanism of head 1200 includes a verticalrail 1207 and a motor 1209 which moves pipette assembly 1202 alongvertical rail 1207 relative to main board 1201.

Additionally, pipette assembly 1202 is similar to pipette assembly 502in that it includes a tip ejector assembly and pipette channel assembly.In particular, the pipette channel assembly is similar to the pipettechannel assembly of pipette assembly 502 in that it includes a channelhousing 1210, tip adaptor 1220 extending from housing 1210, a controlunit 1215 connected to housing 1210, and a connector arm 1217 coupled tocontrol unit 1215.

However, pipette assembly 1202 differs from pipette assembly 502 inrelation to the tip ejector assembly. In particular, it was previouslydescribed with relation to assembly 502 that a leadscrew 540 operates apusher nut 570 that engages a floating shaft 560 connected to a tipejector 550 in order to deliberately eject a pipette tip. However, asshown in FIG. 25D, a leadscrew 1280 directly connects to a tip ejector1250 to eject a tip 489.

Thus, as depicted, the tip ejector assembly of head 1200 includes anejector housing 1240, motor 1290, tip ejector 1250, and leadscrew 1280.Housing 1240 includes an opening extending through a length thereof anda recess 1244 extending through an end of housing 1240. Recess 1244 doesnot extend entirely through housing 1240 and, thus, defines a terminalsurface 1246 at an end of recess 1244.

Motor 1290 is attached to an upper end of ejector housing 1240 andincludes a drive shaft 1292 extending therefrom. Drive shaft 1292 isconnected to leadscrew 1280 via a coupling 1282, such as a slipcoupling. Leadscrew 1280 extends through the opening such that athreaded portion 1286 extends from a bottom of housing 1240.

Tip ejector 1250 is similar to ejector 550 in that it includes acannulated body 1252 and an arm 1258 comprised of a horizontal portion1256 and vertical portion 1258. However, arm 1258 includes an opticalsensor 1251 at a terminal end thereof. As assembled, tip adaptor 1220extends through an opening of cannulated body 1252 and cannulated body1252 is slidable along a length of tip adaptor 1220. Leadscrew 1280 isthreadedly connected to horizontal portion 1256, and vertical portion1258 extends into recess 1244 such that optical sensor 1251 is directedat terminal surface 1246.

In a method of operation of pipette head 1200, pipette head 1200 ismoved into a position over a disposable pipette tip 489 via a pipettearm, such as pipette arm 481. Motor 1209 drives pipette assembly 1202along a vertical rail 1207 toward tip 489. At this point, leadscrew 1286and tip ejector 1250 are in a tip-on position in which the leadscrewthreads have driven tip ejector 1250 upward such that a bottom edge 1259of tip ejector 1250 is positioned above engagement features of tipadaptor 1220. In this position, optical sensor 1251 disposed at theterminal end of vertical portion 1258 is near terminal surface 1246within recess 1244 which generates an output signal indicative of thetip-off position due to the detected closeness of optical sensor 1251and surface 1246. Motor 1290 further drives head 1200 such that pipettetip 489 connects to tip adaptor 1220 in an interference fit manner.

Pipette head 1200 is now ready for aspiration and dispense. Onceaspiration and dispense is completed, pipette head 1200 is positionedover a receptacle opening in first pre-analytical processing deck 24 andtip 489 is ejected. More particularly, motor 1290 is operated in a firstdirection which rotates leadscrew 1280 in the first direction, therebydriving horizontal portion 1256 of tip ejector 1250 along threadedportion 1286. An edge 1259 of cannulated body 1252 is in contact withtip 489. Motor 1290 continues to drive leadscrew 1280 and cannulatedbody 1252 pushes tip 489 off of tip adaptor 1220. Optical sensor 1251determines when tip ejector 1250 is in a tip-off position or hastraveled a sufficient distance, which may be predetermined, to eject tip489 which shuts off motor 1290. Motor 1290 then operates in a seconddirection which rotates leadscrew 1280 in the second direction therebyraising tip ejector 1250 back into the tip-on position in order toretrieve another pipette tip 489.

Furthermore, as shown in FIGS. 25C and 25D, pipette assembly 1202 ishingedly connected to main board 1201 such that pipette assembly 1202can rotate about a vertical axis relative to main board 1201 from afirst position to a second position. In particular, pipette assembly ishingedly connected to a carriage 1205 which is slidingly connected tovertical rail 1207. In the first position, as shown in FIG. 25A, ejectorhousing 1240 is in line with or facing main board 1201. In the secondposition, pipette assembly 1202 is pivoted about 180 degrees so as toassume a folded relationship with respect to main board 1201 which canreduce the amount of space occupied by pipette assembly 1202. A bracket1208 can be used to hold pipette assembly 1202 in this position.

Alternative Computing System Architecture

FIG. 26 depicts a computer system architecture 1300 that supports thesystem according to another embodiment of the present disclosure.Architecture 1300 generally includes a workflow computer control device1330, a pre-analytical system computer control device 1350, and one ormore analyzer computer control devices (illustrated here as two suchcontrol devices 1360, 1370; one for each analyzer). As shown, workflowcomputer control device 1330 is connected to an IP network 1310, whichis also connected to a laboratory information system 1340 (“LIS”). LIS1340 may be an existing generic or customized system associated with adiagnostic laboratory or medical facility that stores and maintainspatient records and information, among other things IP network 1310allows workflow computer control device 1330 to communicate with LIS1340 and share information therebetween. Workflow computer controldevice 1330 is also connected to a cross-instrument bus 1320 along withcomputer control devices 1350, 1360, and 1370. Although, more or lessanalyzer computer control devices may be provided depending on thenumber of analyzers utilized with system 10. This cross-instrument bus1320 allows computer control devices 1350, 1360, and 1370 to communicatewith workflow computer device 1330 and share information.

Workflow computer device 1330 includes one or more processors andmemory. A user interface 1332, similar to user interface 810, isconnected to workflow computer device 1330 to allow a user tocommunicate therewith. In addition, barcode scanners 1334, such asscanner 205, which are located within system 10 and within any of theanalyzers, are connected to workflow computer control device 1330. Thememory of the workflow computer control device 1330 may include anapplication stored therein. This application provides instructions tothe processor of device 1330 that involve gathering data from variousconsumers, compiling the data as instructed, and presenting data tovarious consumers. Such consumers include a user via user interface1332, LIS 1340, barcode scanners 1334, pre-analytical system computerdevice 1350, and analyzer computer control devices 1360, 1370. Inaddition, such exemplary data may include the assay or assays to beperformed on a particular sample (data from LIS to devices 1350, 1360and 1370), instrument and sample status (data from devices 1350, 1360,1370 to user), and assay results (data from devices 1360, 1370 to userand/or LIS). In this regard, workflow computer control device 1330 actsas an information hub.

Pre-analytical system computer control device 1350 is similar tocomputer control device 802 in that it includes a processor and memory.Computer control device 1350, in addition to being connected tocross-instrument bus 1320, is connected to a module bus 1352 which isconnected to the pre-analytical modules 1354 of system 10, such asmodules 710, 720, 730, 740, 750, and 760, allowing computer controldevice 1350 to communicate therewith. Computer control device 1350includes an application stored on its memory which provides instructionsto its processor involving control of the physical operations utilizedin preparation and preprocessing of samples within system 10. In thisregard, the application via the processor of computer control device1350 helps control each instrument/device within pre-analytical modules1354.

Analyzer computer control device 1360 may also each include a processorand memory. Computer control device 1360, in addition to being connectedto cross-instrument bus 1320, is connected to a module bus 1362 which isconnected to analyzer modules of an analyzer A₁, allowing computercontrol device 1360 to communicate therewith. Computer control device1360 includes an application stored on its memory which providesinstructions to its processor involving control of the physicaloperations utilized in analysis of a sample provided to analyzer A₁ viasystem 10. In this regard, the computer control device 1360, via itsprocessor, helps control each instrument/device within the analyzer A₁.Computer control device 1370 is similarly configured for its respectiveanalyzer.

Thus, as shown in FIG. 26, workflow computer control device 1330receives information from multiple inputs and distributes theinformation as needed. This allows system 10 to be fully integrated withone or more analyzers and with an information sharing network thatallows system 10 to smartly perform preparation and preprocessing ofmultiple different samples contained in multiple different containers.However, full integration is not required. The pre-analytical system canbe operated as a stand-alone system and the samples, once prepared, canbe removed and carried to an associated analyzer for analysis.

In another embodiment of architecture 1300, pre-analytical systemcomputer control device 1350 may also act as the workflow computercontrol device 1330. Thus, in such embodiment, device 1350 would bedirectly connected to IP network and also to user interface 1332 andbarcode scanners 1334 as well as cross instrument bus 1320 and modulebus 1352.

Workflow Embodiments

Further to FIG. 26, FIG. 22A illustrates one example of the process flowperformed by the pre-analytical system module. The process flow allowsbatch processing of samples that may or may not require conversion (i.e.the LBC samples in primary container types 01 and 02) and samples thatwill require conversion (e.g. the samples received in primary samplecontainer type 03 which are processed into secondary containers forbatching and transfer to an analytical module(s) for testing).Specifically, and with reference to FIG. 34, the user loads thepre-analytical system with samples and consumables. The samples asreceived have a unique identifier (i.e. an accession number) thereon.The type of rack informs the system of the type of samples in the rack,but the specifics of the samples are not known to the pre-analyticalsystem until the system reads the information on the particular samplecontainer. Since the objective of the system is batch processing (i.e.aggregating samples together that will be subjected to the same test inone of the analyzers in communication with the analyzer), the samplesthat are conveyed into the pre-analytical system may be regrouped tomeet batch requirements. The pre-analytical system initially aggregatesracks of samples and secondary tubes in the consumable accumulationmodule (760 in FIG. 19B).

When the pre-analytical system retrieves a rack from the consumableaccumulation module onto the deck, the rack is scanned for informationthat indicates whether the sample tubes are to pass through thepre-analytical module directly to an analytical module or if the samplestubes cannot be passed through in which case the primary sample must bedrawn from the sample tubes and a secondary sample is prepared forpre-analytical processing. The pre-analytical computing device 1350 willprovide different processing instructions depending upon thedesignation.

The pick and place robot 410 (described elsewhere herein) retrieves asample container from the rack and places the sample container inprimary sample container station 140. The sample preparation/handling ofthe primary sample container is controlled in the following manner.Using a label reader, the reader sends the accession code for the sampleto the pre-analytical computing device 1350, which has been informed ofthe assay workflow ordered for that sample by the workflow computingdevice 1330. If the sample is not to be further prepared, the workflowfor that sample is determined and it is sent to queue (in rack space114, 116). If a sample is received in a container that cannot be handledcompletely by the pre-analytical system, but there is no samplepreparation ordered for the sample, that sample container will beflagged as an error and not be processed further.

If the sample is to be prepared, a secondary tube is retrieved by thepick and place robot 410 and its preassigned serial number is associatedwith the accession number for the sample. As noted elsewhere, a sampleis “prepared” if the primary sample itself is removed from the containerthat carried the sample into the pre-analytical system. For example, asample that is received by the system in a container that cannot becompletely handled by the pre-analytical system, that primary sample isremoved from the container in which it was received and placed in asecondary sample container that can be handled by the system. In otherexamples, the pre-processing instructions for a primary sample willrequire the pre-analytical system to add pre-processing reagents (e.g. adiluent, a buffer, etc.) to the primary sample to create a secondarysample. In one example, the controller then causes the robotic pipettorto transfer predetermined aliquots of sample from the type 03 samplecontainer into the empty tube thereby creating an ISBT (InternationalSociety of Blood Transfusion) 128 standard compliant designation for thesecondary sample. The ISBT 128 Standard was specifically designed tomeet the special traceability needs of medical products of human origin(MPHO) to provide the donor to patient link of each product. Inparticular, it incorporates the identification of the donor within thestandard to ensure this identification is globally unique and ispresented in a standard format to be understood across different deviceplatforms. ISBT 128 is well known to the skill in the art and is notdescribed in detail here. Further information on ISBT 128 can be foundat www.icbba.org/isbt-128-basics. After the rack of ISBT's is completedit is also brought to queue. Here, sensors determine if the queue isfull and receives instructions from the controller on what furtherprocessing is required.

As described elsewhere herein, the pre-analytical system inquires if ananalyzer is available to process a batch of prepared samples. Thisrequires the pre-analytical computing device 1350 to send information tothe workflow computing device 1330, which can ascertain the availableprocessing resources for analyzers A₁ and A₂. Once the pre-analyticalcomputing device 1350 receives a signal that indicates it may prepare agiven batch to a designated analyzer, the rack with the batch of samplesis moved to the rack location 200 using rack elevator 360. Transfer iscontrolled by the pre-analytical computing device 1350. The workflowcomputing device 1330 instructs the pick and place robot 410 todepopulate the sample tubes from the rack into batch accumulation area210. If workflow computing device 1330 instructs, the pick and placerobot 410 places the sample tubes in the warmer 230. The workflowcomputing device 1330 instructs the pick and place robot 410 to load theshuttles on a batch basis.

The workflow computing device 1330 then coordinates the actions of thepick and place robot and the shuttle handling assembly 240 to assemble abatch of samples into a shuttle. The shuttle handling assembly 240 andthe specifics of its operation are described elsewhere herein. The batchitself has been predetermined. Once a batch is assembled in a shuttle,the workflow computing device controls the placement of the shuttle 280onto the shuttle transport assembly 300.

Additional detail on sample preparation/conversion is illustrated inFIG. 22B (samples are for an HPV assay). A variety of reagents andcontainers, disposed in racks, are received at the illustrated station.Examples of inputs to the station include racks carrying containershaving controls for positive and/or negative assay results (i.e. spikedsamples and clear samples). Racks carrying LBC samples requiringpreparation/conversion are also input, as are conversion consumables(i.e. type 03 containers). Output of the preparation/conversion are thecontrols (which may be dried reagents and to which only diluent is addedto prepare the controls for analytical processing), the prepared samplesand waste. Sample preparation/conversion is controlled by thepre-analytical system computing device 1350 without direction or controlfrom the workflow computing device 1330 that is external to thepre-analytical system.

In one embodiment the pre-analytical system has parallel workflowsfor: 1) the control samples; 2) the LBC samples; and 3) the non-LBCsamples. Note that all samples are placed in the spinner/reader samplecontainer station 140. For the LBC and non-LBC samples, as described inthe explanation of FIG. 8A, the sample racks carrying the samplecontainers are positioned adjacent the sample holder container stations140, 150 and the sample tubes are placed individually in a receptacle142 where they are vortexed and decapped. If the samples are not in aprimary sample container that can be directly passed to the analyzers,sample is then aspirated from the sample tube in station 140 bycontrolling the pipetting robot 480 described elsewhere herein bycommunication between the pre-analytical system computing device 1350and the pipetting robot 480. As described elsewhere herein, pipettingrobot 480 is controlled to travel within envelope 680 to retrieve anddispose of disposable pipette tips and to aspirate and transfer analiquot from a primary first-type or second-type container 01, 02 at theprimary sample container station 140 to the secondary third-typecontainer 03 at secondary sample container station 150.

After aspiration, the pre-analytical computing device 1350 sendsinstructions to the diluent dispenser 170 to dispense a predeterminedaliquot of diluent into the secondary sample containers. Regarding thecontrol tubes, the pre-analytical system, based on the instructionsassociated with the control sample via the accession number on thesample container (such processing instructions communicated to thepre-analytical computing device 1350 from the workflow computing device1330) issues instructions to the decapper robot 450 to decap the controlsample. After decapping, the pre-analytical computing device 1350 issuesinstructions to the diluent dispenser 170 to wet the control reagents,after which the control is recapped by the decapper robot 450.

Once the operation for which the sample container has been decapped iscomplete, the decapper robot 450 receives instructions to recap thesample container. After the sample has been recapped, the pick and placerobot 410 receives instructions to place the recapped sample into samplerack 50. In some embodiments, the sample containers with a common batchdesignation can be grouped together in sample rack 50, but this is onlyfor efficiency and is not required. The pre-analytical computing device1350 controls the population of the rack 50 by the pick and place robot.Once the rack 50 has been populated according to the instructionsprovided by the pre-analytical computing device 1350, and thatinformation has been conveyed to the pre-analytical computing device1350, the rack elevator 360 is activated to convey the rack 50 to space200 where the sample containers are unloaded to the batch accumulationarea 210 by the pick and place robot 410. Again, the unloading of thesample containers to the batch accumulation area is controlled based oninstructions from the pre-analytical computing device 1350.

An embodiment of a process flow for whether or not a sample should bepre-warmed in 230 according to such instructions is illustrated in FIG.22A. Again, the “window” into this workflow is the information about thesample encoded on the sample container. That information, includingprocessing instructions, is provided from a look up table in a processor(e.g. the pre-analytical computing device 1350). Every sample to betransported from a sample rack in space 114 in the first pre-analyticalprocessing deck 24 is read by the scanner in the conversion assembly130. As noted above, the scanner communicates with a processor such asthe pre-analytical computing device 1350. If the sample is a retest, andhas already been pre-warmed, the pre-analytical computing device retainsthis information. If the workflow associated with a particular samplerequires a pre-warm, the pre-analytical computing device 1350 so flagsthe sample in the system. The samples are associated into batches basedon the assay information (e.g. a group of samples for an HPV assay arebatched together). The pick and place robot 410 places samples read bythe scanner 130 into batches and the samples are populated into racks 50for transport to the batch accumulation area 210. A virtual queue isprepared by the pre-analytical system computing device 1350. The queueis developed for batches where none of the samples require a pre-warmingstep, where only some require a prewarm step (and some do not) or allrequire a prewarm step. Once the queue is determined by thepre-analytical computing device, the batch is released. Such releaseresults in instructions being sent to pick and place robot 410. Thesamples in the released batcher are populated into the vortexer 220.When vortexing is completed, the samples are depopulated from thevortexer 220 and either sent for pre-warm and then to the cooler or, ifthe pick and place robot is so instructed by the pre-analytical systemcomputing device 1350, the samples are populated directly into a shuttle280. Shuttle population is controlled by the pre-analytical systemcomputing device 1350 in communication with a pick and place robot. Inthose instances where only a portion of batch samples requirespre-warming, receptacles in the shuttle are reserved for the samples inthe batch that will be populated into the shuttle after pre-warming iscompleted. If none of the samples in a batch require pre-warming, thesamples in the batch are populated directly into shuttles 280 by thepick and place robots after being vortexed from instructions provided bythe pre-analytical computing device 1350.

In one embodiment, prior to sample processing of the sample containersin a rack, the pre-analytical system computing device has developed apre-processing queue and a conversion queue. These queues are developedfrom batch information and processing information.

The queue instructions from the pre-analytical device cause the rack 50to be selected from the main storage deck. From the rack type (whichidentifies the sample container type; e.g. Surepath containers, Tripathcontainers, etc.), the pre-analytical system computing device instructsthe pick and place robot to remove samples that require a dual test anddo not require conversion. For those samples requiring conversion, thosesample containers are inspected by camera and if any sample tubes lack acap or are already pierced, the rack is flagged as one with errors andis returned to the hotel. The pre-analytical computing device 1350 isupdated with this information.

If the camera detects no errors, the barcodes on the samples are readand are placed in the primary sample container station where they arevortexed. The sample label is inspected to read the accession number. Ifno accession number is found, the sample is returned to the rack as notcapable of being processed and the information about that sample isupdated. If the accession number is read, sample conversion is performedin the sample conversion assembly 130 according to the processinginstructions provided to the sample conversion assembly 130 from thepre-analytical computing device 1350. This process is repeated for eachsample tube in the rack. The number of tubes removed from the rack areincremented, and sample conversion is complete when the incrementednumber of tubes equals the number of tubes in the rack. When sampleconversion is complete for a sample, the secondary sample container isconveyed to a rack in third sample rack space 114/116. The rack 50 withthe sample containers from which the aliquot of sample was obtained forconversion is returned to the hotel.

If the received rack is determined to be a pass through rack (i.e. thesamples in containers do not require conversion) that rack is inspectedby the camera for the presence of tubes that might require conversion(i.e. blood collection tubes). If the rack is determined to carry bloodcollection tubes, that information will cause the pre-analytical systemcomputing device 1350 to place that rack in queue for conversion. If therack contains a mixture of tubes, that rack is flagged as having issuesthat prevent further processing. Such information is conveyed to boththe pre-analytical computing device and the workflow computing device.

If the received rack does not contain any blood collection tubes, thebarcode of each sample is read as described above. The barcodeinformation is transmitted to the workflow computing device for samplepreparation instructions. If there are tube codes that indicate the tubeis empty, the pre-analytical system computing device 1350 determineswhat assay and sample type are associated with the empty tube. If thetube code is linked to an accession number, the tube is processedaccording to the assay protocol assigned to the accession number. In theillustrated embodiment the assays are GBS, HPV, urine, etc. If there areno empty tubes codes, the sample is configured for information that willindicate whether or not the tube is a “neat tube.” Such tubes containsamples that do not require preparation. Whatever the tube type, thepre-analytical system computing device typically has workflowinstructions that will associate with the code or accession number onthe sample container. If the sample is not a “neat tube” and it lacks anaccession number, then the tube is placed back in the rack withoutfurther processing. If there is an accession number, the sample isprocessed according to the assay or assays linked to the accessionnumber. Depending upon the assigned assay the tube is placed in queueand batched with other samples for that assay. This sorting isdetermined by the pre-analytical system computing device 1350. Thesamples are routed to the batch accumulation area and are furtherprocessed according to the assay instructions (i.e. vortexing, pre-warm,loading batches into shuttles, etc.) The workflow will depend on theassay assigned to the accession number and the sample type (e.g. urine,swab, LBC, etc.). The HPV assay requires sample processing steps such aspre-warm that other assays do not require. For certain assays, thesample will require preparation even if the primary sample container isa type 03 tube that can be handled completely by the pre-processingsystem.

The samples are sorted into batches by the pre-analytical systemcomputing device. Such sorting is virtual. When the complete batch ispresent in the batch accumulation area 210, the pre-analytical computingdevice determines if a shuttle is available to receive the batch. Anycontrols in the batch will have been rehydrated (if required) by thepre-analytical system. As previously described, if the assay requirespre-warming, then those samples that so require are prewarmed and thenthe shuttle is loaded with the batch. Once loaded the shuttle 280 istransported by the shuttle handling assembly 240 to an outbound belt. Bythis point, the shuttle should be carrying all prepared samples, allsamples that did not require preparation (LBC samples) and any controlsfor the batch (e.g. HPV assay controls). The pre-analytical computingdevice, in communication with the workflow computing device, hasdetermined that the analyzer needed to perform the assay on the batch isavailable by exchanging information about the batch with the analyzercomputing device. Such information exchanged will be batchidentification information, barcode information for the shuttle and thesamples in the shuttle. The shuttle is then conveyed by the shuttletransfer assembly to the designated analyzer. During transfer, thepre-analytical system computing device interrogates the belt sensors andthen waits for a signal from the analyzer to indicate a completedhand-off. The analyzer computing device 1350 sends a signal to theanalyzer computing device 1360 that it is ready to receive the shuttle.Sensors are activated by the pre-analytical system computing device and,when sensor confirm that the belts are working properly, the shuttle isconveyed back to the shuttle handling assembly 240. When received, thepre-analytical computing device receives a signal from the shuttlehandling assembly 240 and the pre-analytical computing device 1330 sendsa signal to the analyzer computing device 1360 that the shuttle 280 hasbeen received. Since one batch can be more than one shuttle; thepre-analytical system queries whether the shuttle was the last in abatch. If not, the process is repeated.

In one embodiment of a workflow for LBC samples and for samplecontainers that require conversion, the workflow presumes racks of LBCsample and sample containers that require conversion have been loadedinto the system and stored in the hotel. The pre-analytical systemcomputing device then calls for a rack of the LBC samples, which areprocesses through the sample conversion assembly 130. If there aremultiple such racks, they can be placed in the all available rackpositions associated with sample conversion assembly. This allows theuse of multiple decappers, and pick and spin apparatus to process theplurality of LBC containers. Once there are no more LBC sample racks toprocess, the pre-analytical system computing device 1330 then ordersracks carrying samples that require sample conversion. If there are,such racks are conveyed from the hotel to the sample conversionassembly. The pre-analytical computing device controls conversion of thesamples from the sample container into the secondary sample containersfor processing. The rack with the samples from which sample aliquotswere obtained is then returned to the hotel. If there is no rack readyfor conversion, but the pre-analytical computing device determines thatthere is room in the sample queue, the pre-analytical computing devicequeries inventory to determine if there are any racks that do notrequire sample conversion (i.e. a pass through rack). Once samples areprocessed out of a rack by the sample conversion assembly 130, the racksare returned to the hotel.

When the processing queue is full, the resources of the sampleconversion assembly can be used to inventory both LBC sample-containingracks and racks of samples that require conversion. Referring to FIG.22E, the pre-analytical computing device coordinates the processing ofsamples out of the rack as described above, but the processed or passthrough samples are held in the on the first preparation deck 24 and nottransported to the second preparation deck 26 until the queue can acceptthem. Once the samples are inventoried on the first preparation deck 24the rack carrying the samples to the sample conversion assembly isreturned to the hotel.

In one embodiment of the workflow, the pre-analytical computing devicedoes not know from the accession number the specific assay at the timethat the sample is being prepared. So parallel processing occurs whenthe samples are retrieved from the rack and placed in the sampleconversion apparatus 130. The sample is placed in the bar code reader.The barcode is sent to the workflow computing device as the sample isplaced in the vortexer of the sample conversion apparatus. Duringvortexing, the pick and place apparatus 410 retrieves an empty secondarysample processing container, the barcode is read and it is decappedwhile in the secondary sample container station 150. Parallel to this,the workflow information is received by the pre-analytical systemcomputing device 1350. The computing device waits for a predeterminedtime and, if no information is received, a second predetermined time. Ifa reply is received before a time out, the sample tube is decapped usingdecapper 450; sample is aspirated from the sample tube and inoculatedinto the secondary sample container using robotic pipettor 480. Diluentis then dispensed into the secondary sample container on instructionsfrom the pre-analytical computing device 1330, after which time thepre-analytical computing device is recapped. The secondary samplecontainer is linked to the primary sample container by thepre-analytical computing device 1350.

If the query to the laboratory information system times out, the samplecontainer is returned to the rack and another sample retrieved.Optionally, the query can be attempted again, and, if a reply isultimately received, then the sample container will need to be obtainedfrom the rack.

For samples that do not require conversion, there is no parallelprocessing and the sample is placed in queue while waiting for theworkflow information for those samples. If no reply is received from thelaboratory information system regarding the assays for the queriedsample, the sample is ultimately returned to the rack. The sample canremain in queue until the query to the laboratory information systemtimes out.

A process flow for loading racks is illustrated in FIG. 39. When a rackis received into the pre-analytical system, there is a bar code readerthat reads the barcode on the rack. That information is provided to thepre-analytical system computing device 1350. The pre-analyticalcomputing device determines from the bar code whether the rack containssample containers or consumables for sample preparation and testing(e.g. assay control reagents, pipette tips, empty secondary samplecontainers, etc.). If the rack is determined to carry samples, thepre-analytical system computing device queries its memory to determineif the user interface has indicated that the rack is a priority rack. Ifyes, the pre-analytical computing device 1350 places this rack at aplace in the processing queue consistent with its priority designation.If no, the pre-analytical device places the rack at the end of theprocessing queue. The pre-analytical computing device develops a rackprocessing queue that is typically first in and first out, with rackpriority designations received from the user the mechanism by whichracks are advanced in the queue.

For racks of consumables, those are typically placed in the back of thequeue for racks bringing consumables into the pre-analytical system.Therefore, in this embodiment, the pre-analytical computing device 1350manages and updates two queues, one being the sample rack queue and theother the consumable rack queue. Once a rack is assigned a place in itsqueue, the queue is updated in the pre-analytical computing device 1330,which then issues instructions to the rack handler robot 320 to move therack to the storage deck 22.

Pipette Head

FIG. 27 depicts a pipette head 1400 according to another embodiment ofthe present disclosure. Pipette head 1400 is similar to pipette head 500in that it includes a main board 1401 and pipette assembly 1402. Pipetteassembly 1402 is similar to pipette assembly 502 but differs with regardto the connector arm 1417 which is described below. Additionally,pipette head 1400 differs in that pipette head 1400 has an integratedz-axis drive mechanism. In other words, the z-axis drive mechanism ofpipette head 1400 couples main board 1401 to pipette assembly 1402whereas the z-axis drive mechanism of robot 480 couples pipette head500, via main board 501, to pipette arm 481. This allows pipetteassembly 1402 to be moved vertically relative to main board 1401.

Main board 1401 includes a housing or shell 1403 which includes variouscomponents disposed therein that interconnect with pipette assembly1402. For example, in the depicted embodiment, housing 1403 includes aprinted circuit board (“PCB”) 1406 and a valve 1408 disposed therein.PCB 1406 provides data and power to pipette assembly 1402 viainterconnect cable 1404. Valve 1408 connects to positive and negativepressure inputs (not shown). Valve 1408 combines these inputs andoutputs a positive or negative pressure via a single conduit 1409 suchthat the pressure of a liquid or gas disposed within conduit 1409 can beregulated to control sample aspiration.

In this regard, interconnect cable 1404 and conduit 1409 are connectedto pipette assembly 1402 via connector arm 1417 of pipette assembly1402. This differs from connector arm 517 of assembly 502 in thatpositive and negative pressure inputs are connected directly toconnector arm 517. Instead, conduit 1409 and interconnect cable 1404 arerouted through housing 1403 and connector arm 1417 to pipette assembly1402. At pipette assembly 1402, cable 1404 is connected to control unit1494 and control unit 1415, and conduit 1409 is connected to the pipettechannel via control unit 1409.

The z-axis drive mechanism of head 1400 includes a vertical rail 1407,motor 1409, and drive shaft 1411. Vertical rail 1407 extends along anouter surface of housing 1403 and drive shaft 1411 extends into housing1403 adjacent to and offset from vertical rail 1407. Motor 1409 isconnected to drive shaft 1411 and is mounted to an outer surface ofhousing 1403 for ease of maintenance. However, motor 1409 may also bedisposed within housing 1403. Connector arm 1417 is threadedly connectedto drive shaft 1411 so that rotation of drive shaft 1411 drives pipetteassembly 1402 vertically or along a z-axis in up or down directions.Cable 1404 and conduit 1409 may be provided with slack so as to allowconnector arm 1417 to travel vertically without tensioning and possiblydamaging cable 1404 and conduit 1409. Motor 1409 is connected to and iscontrolled by PCB 1406. In this regard, controller 1494 can detectliquid levels via a disposable pipette tip (not shown) and send adetection signal to PCB 1406 via cable 1404. PCB 1406 can control motor1409 in response to such signal which can include stopping the verticaltravel of pipette assembly 1402 in response to a liquid level detectionor moving pipette assembly 1402 a predefined rate in response to suchsignal so as to aspirate a sample into a disposable pipette tip in aregulated manner.

Pipette assembly 1402 is stabilized during vertical travel by verticalrail 1407 being connected to pipette assembly 1402. In particular,pipette assembly 1402 is hingedly connected to vertical rail 1407 via afirst and second hinge mount 1405 a-b Hinge mounts 1405 a-b are slidablyconnected to vertical rail 1407 and are vertically offset from eachother such that connector arm 1417 is disposed therebetween. This allowspipette assembly 1402 to pivot about hinge mounts 1405 a-b withoutinterference by connector arm 1417.

In this regard, pipette assembly 1402 has a first hinge position and asecond hinge position. In the first hinge position, pipette assembly1402 is generally in planar alignment with or at zero degrees relativeto main board 1401 as depicted in FIG. 27. In the second position,pipette assembly 1402 is rotated about hinge mounts 1405 a-b from thefirst position about 180 degrees so that pipette assembly 1402 is inplanar offset from main board 1401 as depicted in FIGS. 28A-29. However,it should be understood that pipette assembly 1402 can be orientedrelative to main board 1401 to any angle between 0 and 180 degrees.

FIGS. 28A and 28B also depict an alternative pipette head embodiment1400′ in which main board 1401 and pipette assembly 1402 are connectedto a backplane connector 1500. Backplane connector 1500 connects mainboard 1401 and pipette assembly 1402 to a pipette arm, such as arm 481.In addition, backplane connector 1500 includes one or more connectors1506 a-e. For example, in the embodiment depicted, backplane connector1500 has a first surface 1502 and a second surface 1504. First surface1502 is connected to a surface of housing 1401 at an opposite side frompipette assembly 1402. Second surface 1504 connects to a pipette arm.First surface 1502 includes several connectors including an Ethernetconnector 1506, a power connector 1506 b, a multipin connector 1506 c,positive pressure input connector 1506 d, and vacuum pressure inputconnector 1506 e. Thus, these connectors 1506 a-e face a directiontoward pipette assembly 1402. More or less connectors may be provided atthis surface 1502 as needed. A PCB 1508 is disposed within backplaneconnector 1500 and connects connectors 1506 a-b to PCB board 1406 withinmain board housing 1403.

FIG. 29 depicts another alternative pipette head embodiment 1400″ inwhich main board 1401 and pipette assembly 1402 are connected to abackplane connector 1600. Backplane connector 1600 is similar tobackplane connector 1500 in that it is connected to main board 1401 andconnects to a pipette arm, such as arm 481. However, backplane connector1600 differs in that connectors are disposed within a backplaneconnector housing and face a direction away from pipette assembly 1402.

The system 10 described herein includes a plurality of roboticmechanisms that translate through a plurality of positions. A homeposition is provided for each mechanism such that, when the system“reboots” after a power outage or reset, the robotic mechanisms are allat their home position at the time of the reboot. In one embodiment, thesystem 10 has a power recovery module. Before returning to normalprocessing, an inventory is performed in the conversion/preparationmodule 710, shuttle processing module 750, and the consumableaccumulation module 760. Based upon the inventory, the system 10compares the last known consumable status before the outage with thepost-outage inventory. After the inventory, the system resumes normalprocessing.

When the system 10, or its components, enters a pause state, the sampleprocessing currently ongoing is completed to the extent possible. Forthose samples in a warmer 230, the warming cycle times out (if cycletimes are equal to or less than a threshold), after which time thesamples are transferred to a cooler 290. To the extent that samples arein queue to be sent to a diagnostic module (A₁, A₂, A_(n)), thosesamples are transferred after a shuttle returns home. From the firstpre-analytical processing deck 24, the sample racks 30, 40, 50 arecleared and placed in the rack storage area 22. An instruction is sentprohibiting samples from being transferred from one deck level toanother until normal processing resumes. All deck level motors are shutoff and the doors to system 10 are unlocked after which a message issent to an operator that the system 10 has entered a paused state.

When recovering from a pause state, the operator first has the system 10re-read the barcode on samples or shuttles removed by the operator inresponse to the pause error. The operator then closes the door andactivates the door lock. The system 10 then interrogates the operator todetermine the cause of the error and the operator response. The system10 then runs through a checklist to address possible problems (e.g., ifa shuttle is in the penalty box, it is evaluated to determine if it hasa stuck pipette tip). The positions of the pick-and-place robots 410 b-care inspected to determine if the back of the apparatus was accessedduring pause and, in doing so, such robots 410 b-c were moved. Robots410 b-c transition to home positions as noted above. If there are tubesin the vortexer 220, the system 10 reenters the pause state so that theymay be removed. If there is a third-type sample container 03 in a tubeholder, the system 10 is re-paused so that the third-type samplecontainer can be removed.

FIG. 22G illustrates embodiments of system responses when an operatorrequests instrument access. In one example, the pre-analytical system isin the process of performing a batch transfer. Any batch transfers inprogress are completed. If there are any samples in prewarm, prewarm iscompleted and those tubes in prewarm are moved out of the warmer. Therobots then move to their home positions. In another embodiment, thereis time threshold for allowing samples to complete prewarm. The prewarmcompletes for those samples where the prewarm time is under thespecified threshold. When prewarm is completed, the samples are movedout of prewarm and the robots return to home, after which the accessdoors are unlocked and the user can access the system. In anotherembodiment the request for access allows batch transfers to complete,pauses further batch transfers, has the robots return to home andunlocks the system for access. In this embodiment, prewarm is allowed tocontinue but the user is notified if any prewarm has timed out.

If a shuttle 280 is in the unload spot, such as on platform 260 c, it isretrieved by the shuttle robot 240, its barcode is read and it isreturned to the unload spot 260 c. If all of the sample containers inthe shuttle 280 are processed, then the shuttle 280 is parked by theshuttle robot 240. If all of the samples are not processed, theunprocessed samples are marked as ejected and a shuttle error isprocessed. Once any and all errors are cleared, the elevator 360 isbrought back online and rack handler robot 320 brings the racks 30, 40or 50 back up to the processing deck.

As noted above, the system 10 proceeds with an inventory when restartingfrom a pause state. For example, the robots within system 10 areinterrogated to determine if they are in their home position. If therobots are not, then the system 10 places them in the home position. Ifthe robots/shuttles/vortexers contain sample containers, the system 10reenters the pause state until the sample containers are clearedtherefrom.

As noted above, the system can either pass-through samples that arealready prepared to be processed by the one or more analyzers.Typically, when racks are loaded into the rack, the samples carried bythe rack are either samples that require conversion or samples that donot require conversion. The information regarding the pre-processingrequirements for the samples carried by the rack is carried by the racklabel. Each sample container also has an accession number which islinked to information about the pre-processing requirements for aparticular sample. The accession number is associated with the sample bythe workflow computing device 1330. When the rack label information andthe sample accession number is communicated to the pre-analytical systemcomputing device 1350, the pre-analytical computing device 1350communicates with the controllers of the various subsystems in thepre-analytical system 10 (e.g. the conversion assembly 130, the rackhandler robot 320, the pick and place robot 410, the robotic pipette480, etc.).

Optional Tray

FIGS. 30A-30D illustrate an optional tray for use with system 10 asdescribed herein. Tray can be utilized for transporting any ofcontainers 01, 02, and 03, which may occur external to the housing ofsystem 10. Such containers are collectively referred to as container1710 in the following description. In addition to being capable oftransporting a plurality of containers 1710, tray 1710 may also be usedto help load any of racks 30, 40, and 50, which are collectivelyreferred to as rack 1720, with respective containers 01, 02, 03.

As depicted in FIG. 30A, tray 1700 has receptacles 1705 adapted toreceive empty consumable tubes 1710. Such sample consumable tubes 1710are typically cylindrical. In addition, tray 1700 includes a handle 1704integrated into an end thereof adjacent receptacles 1705. Tray 1700 hasa vertical profile that allows tray 1700 to be used as a carrier tray1700 for the sample containers and/or as a lid to be placed on top ofsample containers 1710 disposed in another tray.

FIG. 30B illustrates the embodiment where the consumables are receivedwith one tray 1700 supporting one end of the consumable tubes 1710 and asecond tray 1700 retaining the opposite end of the consumable tubes1710. In other embodiments, the consumable tubes 1710 are receivedsupported by only one tray 1700.

FIG. 30C illustrates the embodiment where the consumable tubes 1710 arereceived disposed in one tray 1700. Note that, in this embodiment, theconsumable tubes are oriented upside down, so that a cap end of theconsumable tubes 1710 is supported by the tray 1700. In this orientationrelative to tubes 1710, a rack 1720 with receptacles 1725 therein canreceive consumable tubes 1710 so that rack 1720 can be used to deliverthe consumables tubes 1710 into the automated pre-analytical system 10described herein. The receptacles 1725 in rack 1720 are sized such thatthey cannot receive the cap end of the consumable tubes 1710. Thisensures that the consumable tubes 1710 are delivered into the rack 1720in the proper orientation.

FIG. 30D illustrates the rack 1720 being inverted and brought over thearray of consumable tubes 1710 supported by the tray 1700. As notedabove, the rack 1720 is brought over the consumable tubes 1710 such thatthe bottom end (the end opposite the capped end) of the consumable tubes1710 extends into the receptacles 1725 of the rack 1720. The receptacles1705, 1725 of the tray 1700 and the rack 1720, respectively, aredimensioned to retain the consumable tubes 1710 in a substantiallyvertical orientation but not so snugly that force is required to removethe consumable tubes 1710 from the tray 1700 or the rack 1720.

FIG. 30E illustrates the rack 1720 placed over the consumable tubes 1710supported by the tray 1700. After the rack 1720 is so placed, theassembly illustrated in FIG. 30D is inverted, the tray 1700 removed fromthe assembly and the rack 1720 carrying the tubes 1710 with the cap endsup is placed in the pre-analytical system 10 described herein. Theloading of racks 1720 into the pre-analytical system 10 is describedelsewhere herein.

Alternative Decapper Assembly

FIGS. 31A-31N depict an alternative decapper assembly 2000 to that ofdecapper assembly 470. In this regard, decapper assembly 2000 can becarried by decapper robot 450. As previously mentioned, decapper robot450 can be utilized to move sample containers 01, 02, and 03 to and fromracks 30, 40, and 50, respectively. However, this can be challenging ascontainers 01, 02, and 03 are located in a dense array of rackreceptacles, such as receptacles 32, 42, or 52, so that the distancedirectly between each container is small which limits the useable spacearound a target container for grippers to grip such container. This ismade even more challenging in that the same decapper that retrieves thetarget container also decaps the container. Thus, a decapper assemblyand its container grippers may be bulkier than might otherwise be neededonly for container transport so that the decapper assembly can deliverenough torque to a wide range of container caps. Such torque may be 30in-lbs (3.4 Nm) or less. In addition, many of the containers utilized insystem 10 have a penetrable seal, such as container 03, that should beavoided to prevent incidental and unwanted penetration which couldresult in contamination.

As illustrated in FIG. 31J, sample containers 03 are arrayed in a rack50′, which is a smaller, exemplary version of rack 50. For a decapperhaving three gripper fingers, target locations A, B, and C for eachgripper finger relative to a target container T and to containerssurrounding the target container are specifically located to positioncontainer grippers within useable space and to avoid contacting apenetrable seal. Such locations A, B, and C, may each correspond to aspace within a triangular formation of three adjacent sample containers,one of which being the target container T, wherein each containerdefines an apex of the triangle. Decapper assembly, is configured toconsistently position gripper fingers in such locations A, B, and C andto reliably handle thousands of containers while being able to deliverenough torque to open a wide variety of container caps.

As shown, decapper assembly 2000 generally includes a gripper motor 2002a, a decapper motor 2002 b, a plurality of gears, a plurality of gripperassemblies 2100, a container contact sensor assembly 2060, a rotationalhome sensor assembly, and a guide plate 2050. Gripper motor 2002 a isconnected to a gripper pinion 2004 a. Decapper motor 2002 b is connectedto a decapper pinion 2004 b. The plurality of gears includes first andsecond gripper gears 2010, 2032 and a decapper gear 2020. Second grippergear 2032 is connected to a main shaft 2034 which extends from secondgriper gear 2032 in a direction parallel to a rotational axis thereof,as best shown in FIG. 31M. Main shaft 2034 has a longitudinal openingthat is configured to receive a plunger shaft 2062 which is describedfurther below. Such gears 2010, 2032, 2020 can be made from severaldifferent types of materials including brass, stainless steel, andplastic.

A gripper assembly 2100 is shown in detail in FIGS. 31G-31I. Decapperassembly 2000 preferably includes three gripper assemblies, such as afirst, second and third gripper assembly 2100 a-c. However, more or lessgripper assemblies 2100 are contemplated. Each gripper assembly 2100includes a gripper arm 2120, gripper finger 2130, and a planetary gear2110. A torsion spring 2140, as shown in FIG. 31F, is optionallyprovided in the gripper assembly. As shown in FIG. 31H, gripper arm 2120includes an upper arm portion 2122 and a lower arm portion 2124. Upperarm portion 2122 includes a cylindrical projection 2121 extending in anupward direction and an opening 2123 that extends through the entiretyof upper arm portion 2122 including the cylindrical projection 2121.Bearings 2128 are press-fit within opening 2123 of upper arm portion2122. Planetary gear 2110 is positioned over cylindrical projection 2123and is fixed to upper arm 2122 via a plurality of fasteners 2104.Gripper arm 2120 may be made from a metallic material, such as aluminum,while planetary gear 2110 may be made from a polymer material.Connecting bearings 2128 to upper portion of gripper arm 2122, ratherthan to planetary gear 2110, helps provide robustness and reduces play.

Lower arm portion 2124 has an axis offset from an axis of upper armportion 2122. An opening extends through lower arm portion 2124 which isconfigured to receive a gripper finger 2130 and a fastener 2102, as bestshown in FIG. 31I. A notch 2126 extends into lower arm portion 2124 froman exterior thereof for engagement with torsion spring 2140. Gripperfinger 2130 includes a connection post 2132, a collar 2134 and a gripperportion 2136. Connection post 2132 includes a threaded opening. Gripperportion 2136 is separated from connection post 2132 by collar 2134 andincludes a fully-rounded end 2138 and straight knurling. Fully-roundedend 2138 helps reduce incidence of container pick-up failure byproviding tolerance to misalignment of finger 2130 to the targetcontainer T. When connected to lower arm portion 2124, post 2132 ofgripper finger 2130 is received within the opening of lower arm portion2124 so that collar 2134 contacts a bottom end of lower arm portion 2124and fastener 2102 fixes gripper finger 2130 in position. Thisconfiguration allows gripper finger 2130 to be easily replaced withoutthe need for disassembly of other components.

Container contact sensor assembly 2060 is shown in detail in FIGS. 31Mand 31N. Container contact sensor assembly 2060 includes a sensor 2064a-b, a plunger 2061 and a keyed plunger cap 2065. Plunger 2061 includesa plunger shaft 2062 and an end portion 2063 that has a largercross-sectional dimension than shaft 2062. Keyed plunger cap 2065includes a plurality of fins 2066 extending from a central body 2067. Inthe particular embodiment depicted, there are three fins 2066circumferentially distributed in a proximately symmetric pattern aroundcentral body 2067. These fins 2066 are keyed to slots 2054 in guideplate 2050. In addition, plunger cap 2065 includes extension members2068 that extend radially outwardly from a bottom end of each fin 2066.Central body 2067 includes a threaded opening at one end thereof whichis threadedly connected to shaft 2061. At another end of central body2067, fins 2066 and central body 2067 define a tapering recess 2069.This tapering recess 2069 allows for a cylindrical cap 091 of a samplecontainer 03 to contact fins 2066 at a radial edge of the cap 091without disturbing a penetrable seal disposed inwardly of the radialedge of cap 091, as is illustrated in FIG. 31M. Such tapering recess2069 allows caps of various sizes to contact fins 2066 in this manner.The sensor 2064 may be a Hall effect sensor, optical sensor, or thelike. In the particular embodiment depicted, sensor 2064 is an opticalsensor and includes first and second sensor elements 2064 a-b that areso positioned as to form a gap therebetween. First sensor 2064 a may bean emitter and second sensor 2064 b may be a detector. As describedbelow, end portion 2063 of shaft 2062 may be utilized in conjunctionwith sensor 2064 so that end portion 2063 extends through the gap tointerfere with emissions between first and second sensor elements 2064a-b so as to produce a signal indicating the presence of a cap 091between gripper fingers 20130 which initiates a grip sequence.

The rotational home sensor assembly includes a slotted disc 2040 and asensor 2044. Sensor 2040 may be an optical sensor and may include firstand second sensor elements 2044 a-b similar to that of sensor 2064. Inthis regard, first and second sensor elements 2064 a-b are so positionedas to form a gap therebetween. As described below, slotted disc 2040 maybe utilized in conjunction with sensor 2044 so that disc 2040 interfereswith emissions between first and second sensor 2044 a-b except whensensors 2044 a-b are aligned with slot 242 thereby generating a signalthat rotational home of decapper assembly 2000 has been achieved.

When decapper assembly 2000 is fully assembled, the gripper motor 2002 aand decapper motor 2002 b may be face-mounted to a mounting plate 2072.Mounting plate 2072 is connected to a support arm 2070 which may besuspended from robot 450. The mounting plate 2072 includes notches 2074extending through and edge 2074 thereof which allows motors 2002 a and2002 b to be slid into such notches and fixed to the mount 2072 viafasteners. This allows for easy removal and replacement of motors 2002a-b without extensive disassembly of other components. A first sensorsupport arm 2076 is also connected to mounting plate 2072 and issuspended therefrom. Sensor elements 2044 a-b are connected to firstsupport arm 2076 and are vertically arranged so as to form a gaptherebetween. Sensor elements 2064 a-b are also supported by mountingplate 2072 via a second sensor support arm 2077 that extends abovemounting plate 2072. Sensor elements 2044 a-b are horizontally arrangedso as to form a gap therebetween.

As shown in FIG. 31E, main shaft 2034 of gripper drive assembly 2030extends downwardly through a first angular contact bearing 2079 which ispress-fit into mounting plate 2072. A threaded end cap 2078 is threadedto an end of main shaft 2034 and is positioned above mounting plate2072. First gripper gear 2010 is stacked above decapper gear 2020 whichare both disposed about main shaft 2034. First gripper gear 2010 isfixed to main shaft 2034 via a gripper drive hub 2012 so that rotationof first gripper gear 2010 causes gripper drive assembly 2030 to rotate.Decapper gear 2020 is rotatably connected to main shaft 2034 via anangular contact bearing 2022 press-fit to decapper gear 2020. Theslotted disc 2040 is also arranged about the main shaft 2034 and ispositioned beneath decapper gear 2020. Slotted disc 2040 in thisposition projects radially outwardly beyond decapper gear 2020 so as topartially extend into the gap formed between sensor elements 2044 a-b.Slotted disc 2040 is connected to a bottom side of decapper gear 2020via fasteners 2046 (best shown in FIG. 31E).

In addition, gripper assemblies 2100 a-c and guide plate 2050 areconnected to and suspended from decapper gear 2020 via a plurality ofconnection shafts 2150. In this regard, a connection shaft 2150 extendsthrough slotted disc 2040 and through opening 2123 of upper arm portion2122 of each gripper assembly 2100 a-c and interfaces with bearings 2128so that upper arm 2122 can rotate about connection shaft 2150. A bottomend of each connection shaft 2150 is connected to guide plate 2050. Atorsion spring 2140 is disposed about each connection shaft 2150 betweenguide plate 2050 and gripper assembly 2100. A first arm 2142 of thetorsion spring 2140 is embedded in guide plate 2050, and a second arm2144 of spring 2140 is disposed within groove 2126 of gripper arm 2124(see FIG. 31F). Each torsion spring 2140 has a spring stiffnesssufficient to keep respective gripper fingers 2130 compressed againstcontainer cap 091 so as to maintain control of cap and container in theevent of a power failure. In this regard, torsion springs 2140 provide apower loss fail-safe to prevent decapper assembly 2000 from dropping acontainer and potentially contaminating system 10. Lower arm portions2124 and gripper fingers 2130 project through curvilinear slots 2052 inguide plate 2050 offset from the connection shaft 2150. When eachgripper assembly 2100 is rotated about a respective connection shaft2150, gripper fingers 2130 translate along curvilinear slot 2052.

Plunger 2062 is slidably disposed within the longitudinal opening ofgripper drive member 2050 and extends through main shaft 2034 and secondgripper gear 2032. Plunger shaft 2062 also extends through end cap 2078so that end portion 2063 is disposed above end cap 2078. Keyed plungercap 2065 is slidably connected to guide plate 2050 via fins 2066 whichare positioned within slots 2054 in guide plate 2050. Extension members2068 extend along a bottom surface 2056 of guide plate and act as anaxial stop by abutting the bottom surface 2056 when plunger 2061 movesaxially upwardly a predetermined distance. Gripper motor pinion 2004 ais meshed with first gripper gear 2010. Second gripper gear 2032, whichis positioned beneath decapper gear 2020, is meshed with the planetarygears 2110 of each of gripper assemblies 2100 a-c. Decapper motor 2002 bis meshed with decapper gear 2020. In this regard, gripper motor 2020operates to move gripper fingers 2130 so as to grip and ungrip cap 091,and decapper motor 2002 b operates to rotate assembly 2000 to decap andrecap cap 091. In a method of operation, gripper robot 450 is moved to aposition above a plurality of containers 03 arranged in a dense arraywithin rack 50. Robot 450 moves decapper assembly 2000 downward over atarget container T so that gripper fingers 2130 are positioned abouttarget container in locations A, B, and C. Robot 450 continues to lowerdecapper assembly so that a cap 901 of target container 03 is positionedpartially within tapered recess 2069 and abuts fins 2066 of keyedplunger cap 2065. As robot 405 is continued to be lowered, cap 091pushes plunger 2061 upward so that end portion 2063 of plunger 2061moves into the gap between sensor elements 2064 a-b causing an emissionfrom the sensor 2064 a to be disrupted. Such disruption generates anelectrical signal that communicates with computing device 1350 which inturn initiates a gripping sequence.

In the gripping sequence, gripper motor 2002 a is operated so as torotate gripper pinion 2004 a in a first direction. Gripper pinion 2004 athen drives first gripper gear 2010 which in turn rotates second grippergear 2032. Second gripper gear 2032 drives the planetary gears 2110,which causes gripper assemblies 2100 a-c to rotate about respectiveconnections shafts 2150. As gripper assemblies 2100 a-c are rotatedabout connections shafts 2150, gripper fingers translate alongcurvilinear slots 2052 in guide plate 2050 until cap 091 is securelygripped by gripper fingers 2130. Robot 450 then lifts container 03 outof rack 50 and transports it to another location, such as receptacle152. Should power to motor 2002 a cease at any point during suchtransport operation, torsion springs 2140 will hold container 03 bypushing against lower arm portion 2124 so as to maintain a grip oncontainer 03.

Once container 03 is positioned in receptacle 152 and a bottom end ofcontainer 03 meshes with an engagement feature therein, a decappingsequence is initiated. In this regard, decapper motor 2002 b is operatedso as to rotate decapper pinion 2004 b in a first direction. Decapperpinion 2002 b drives decapper gear 2020. As mentioned above, decappergear 2020 is fixedly connected to slotted disc 2040 and is alsoconnected to gripper assemblies 2100 a-c and guide plate 2050. Thus, asdecapper gear 2020 is rotated by decapper pinion 2004 b, slotted disc2040, guide plate 2050, and gripper assemblies 2100 a-c arecorrespondingly rotated so that gripper fingers 2130 decap container 03.Gripper assembles 2100 a-c hold onto cap until the container is ready tobe recapped. Should the cap fall away from the gripper assemblies,plunger 2061 automatically drops which activates sensor elements 2064a-b indicating to system 10 that cap 091 has been dropped.

When container 03 is ready, decapper robot 450 places cap 091 back ontocontainer 03 and a capping sequence is initiated in which motor 2002 bis operated so that decapper pinion 2004 b is rotated in a seconddirection causing decapper gear 2020 and fingers 2130 to rotate in anopposite direction as in the decapping sequence. Once container 03 isrecapped, robot 450 moves container 03 back to rack 50.

A home sequence may be operated in which decapper motor 2002 b is againoperated so that decapper gear 2020, slotted disc 2040, and gripperassemblies 2100 a-c are rotated. Such rotation occurs until slot 2042 isaligned with sensors 2044 a-b allowing an emission from sensor 2044 a topass through to the sensor 2002 b. This indicates that gripper fingers2130 are in the home position. In this position, gripper fingers 2130are angularly located about a rotational axis extending through secondgripper gear 2032 so that when decapper assembly 2000 is lowered overrack 50, gripper fingers 2030 will be positioned at locations A, B, andC. Thus, once rotational home is indicated, motor 2002 b stops operatingand container 03 is lowered back into rack 50. Fingers 2030 beingpositioned at home prevents fingers 2030 from disturbing adjacentcontainers.

Once container 03 is back in its rack 50, an ungrip sequence isinitiated in which gripper motor 2002 a is operated to rotate gripperpinion 2004 a in a second direction which causes first and secondgripper gears 2010, 2032 to rotate in an opposite direction to that ofthe grip sequence. This causes gripper assemblies 2100 a-c to be rotatedabout connection shaft 2150 so that gripper fingers 2130 are moved awayfrom cap 091. The number of pinion rotations to ungrip cap 091 withoutbumping into adjacent containers can be preprogramed and verified duringoperation by an encoder of motor 2002 a. With fingers 2130 still in therotational home position, decapper assembly 450 can be moved to anothercontainer to perform the same method. In this regard, fingers 2130 willbe located in positions A, B, and C relative to the next targetcontainer so that fingers 2130 can be located in respective spacesadjacent the target container sufficient for gripping the containerwithout disrupting adjacent containers.

Alternative Warmer FIGS. 32A-32C depict a batch warmer array 2200according to another embodiment of the present disclosure. Batch warmerarray 2200 may be utilized as a substitute for warmer 230. Batch warmerarray 2200 includes a plurality of batch warmers 2210 a-c arrangedadjacent one another. As shown, the array 2200 may include a first,second and third batch warmers 2210 a-c. Referring to the cross-sectionof FIG. 32A in FIG. 32B, each warmer 2210 includes a cover 2220, upperinsulation layer 2232, lower insulation layer 2242, upper conductionblock 2234, lower conduction block 2244 and heater 2250. Heater 2250 inthis particular embodiment is a thin sheet heating element, such as aKapton® heater, which is sandwiched between an upper layer 2230comprised of the upper insulation layer 2232 and conduction block 2234and a lower layer 2240 comprised of the lower insulation layer 2242 andconduction block 2244. In this particular arrangement heating is fromthe middle out which helps generate a uniform distribution of heatwithin the conduction blocks 2234, 2244 between the insulation layers2232, 2242 as the heat tend to flow outwardly toward the coolerexterior. Conduction blocks 2234 and 2244 may be made from any heatconductive material, such as aluminum, and define, along with upperinsulation layer 2232 and cover 2220, a plurality of sample containerreceptacles 2212. The number of receptacles 2212 may be selected basedon the number of containers 03 typically processed in a batch. Thus,each batch warmer 2210 is configured to warm an entire batch of samplesor less. Conduction blocks 2234 and 2244 have a combined height so thatwhen a sample container 03 is disposed within a receptacle 2212, asample 03′ contained within the container 03 is disposed substantiallybetween ends 2236 and 2246 of the conduction blocks 2234, 2244 so thatheat emanating therefrom uniformly encompasses the sample 03′. Atemperature detector 2252, such as a pair of resistance temperaturedetectors, are located at the middle of a receptacle array 2214 andadjacent heater 2250. A thermal cut-off 2254 is provided to preventoverheating of batch warmer 2200. The cover 2220, which is preferablymade from a polymer material, such as a Kydex®, surrounds and containsthe insulation layers 2232, 2242 and conduction blocks 2234, 2244. Thus,each warmer 2210 of the array 2200 is thermally isolated from oneanother.

Batch warmer array 2200 has many advantages one of which is itssuitability to batch processing. As previously described, system 10 canprocess batches of samples to be distributed to an analyzer which mayinclude pre-warming the batch. In this regard, a first batch may beloaded into first warmer 2210 a. At some time later, a second batch maybe loaded into second warmer 2210 b. The isolation of first warmer 2210a from second warmer 2210 b prevents the second batch, which may becooler than the first batch when loaded into second warmer 2210 b, fromimpacting the warming cycle of the first batch.

Cooler

FIGS. 33A-33B depict a cooler 2300 according to a further embodiment ofthe present disclosure. Cooler 2300 is similar to cooler 290 in that itincludes a plurality of fan units 2330, a plenum 2340, a mounting plate2320, and a container rack/block 2310. In this regard, block 2310 ismounted to one side of plate 2320, and plenum 2340 and fans 2330 areconnected to another side of mounting plate 2320. However, cooler 2300differs in that it includes a mounting bracket 2350 for mounting cooler2300 to second pre-analytical processing deck 26 so that fans 2330 arepositioned at a predetermined height above second deck 26 to allow fans2330 to draw a sufficient volume of air into their respective inlets2332 to cool containers 03 disposed in block 2310. In addition, block2310 is a single block rather than a plurality of blocks as is the casewith cooler 290. Also, block 2310 defines a plurality of samplecontainer receptacles 2312 that each have a square shaped opening andinclude ribs 2314, such as four ribs, extending along interior surfacesthereof. These ribs 2314 form air flow channels therebetween for air toflow over and around each sample container 03 disposed withinreceptacles 2312 for even cooling.

Automated Workspace Location Detection

The controller(s) (e.g., microcontroller(s)), with one or moreprogrammable processors, of any of the aforementioned robots may beprogrammed to control the robot(s) to conduct an automatic searchpattern within its workspace (e.g., the space including the moveablelimits of the motors of the robot) for calibrating the robot for movingto particular locations within the workspace. The search pattern is partof an automated process, such as of the computer system 800, thatpermits each robot to learn one or more positions within its respectiveworkspace by using one or more fiducial beacons. Such an automatedprocess can reduce the need for trained technicians to calibrate therobot so that, through the automated learning process, the robot canlearn to repeatedly and accurately move to the various positions of theworkspace (e.g., sample locations of a rack etc.).

For example, a controller may control the automated learning process.The controller may be integrated with the computer system 800 asillustrated in FIG. 20 such that it may be the computer system 800 or incommunication with the computer system 800. Such a system with thecontroller is further illustrated in FIG. 34. The controller 8000 willtypically include one or more processors configured to implementparticular control methodologies such as the search pattern algorithmsdescribed in more detail herein. To this end, the controller may includememory 8006 such as integrated chips, and/or other control instruction,data or information storage medium. For example, programmed instructionsencompassing such a control methodology may be coded on integrated chipsin the memory of the device. Such instructions may also or alternativelybe loaded as software or firmware using an appropriate data storagemedium.

In this system, the controller 8000 includes/uses input/output elementssuch as of, or coupled to, bus 8001. The input/output elements enableone or more processor(s) 8004, to receive signals from an auto-learnsensor 34010. The sensor may be configured to detect a fiducial beaconthat when proximate (in a near vicinity) to the fiducial beacon canprovide a signal to the sensor. In this regard, the fiducial beacon mayprovide a signal field so that its detection can be completed withoutcontact between the fiducial beacon and the sensor. For example, thesensor may preferably be a Hall-effect sensor and the fiducial beaconmay be magnetized so as to provide a magnetic field. Thus, the fiducialbeacon may include a magnet such as an electromagnet or a permanentmagnet. In some cases, the fiducial beacon may be a cone-ended magnet(e.g., a magnet with a cone shape). In this regard, such fiducialbeacons may be located within the workspace of the robot. The roboticsample handler may then be equipped with the sensor, such as byinserting a removeable sensor into a gripper of the robotic handler forthe calibration procedure, or by providing the robot with an integratedsensor. The controller may then conduct the search pattern to locate oneor more the fiducial beacons in a workspace of the robot. The fiducialbeacons may be permanently located within the workspace or may beremovable components that are inserted for the auto-learn process.

The input/output elements also permit control by the processor(s) of oneor more robots, such as a robotic sample handler 34020, including, inparticular, the motor(s) of the robot. In this regard, the roboticsample handler may be any of the robots as previously described,including for example, rack handler robot, rack mover arm, support beamrobot, pipetting robot, robot 320, pick and place robot, shuttlehandling robot, shuttle robot, rack elevator robot, decapper robots,etc. Thus, the processor may control the robot(s) via the input/outputelements so as to send control signals to operate each motor of thehandler 34020 and detect each motor's position such as byreading/receiving signals or data from an encoder (e.g., a rotaryencoder) associated with the controlled movement of each motor. In thisregard, each motor may provide movement of the robot on/along orrelative to a particular axis and the encoder may provide an informationsignal or count that is associated with a particular position on theaxis of the robot. In this regard, in some cases a robot may have one ormore motors, such as a least two motors that allow positioning of ahandler of the robot on two axes (e.g., an x axis and y axis which maybe perpendicular to each other) of a workspace. In some cases, a robotmay have an additional motor for positioning the handler on three axes(e.g., an x axis, y axis, and z axis which may each be perpendicular toeach other) of a workspace. In some cases, a robot may have a singlemotor for positioning the handler along a single axis of its workspace.

In some cases, sensing a position of a particular location of a fiducialbeacon may be prone to errors. For example, use of Hall-effect sensorscan have varying results when trying to detect a precise position withina workspace. The sensors and/or magnets can have varying characteristicssuch that it is difficult to obtain a correct position consistently withthe such sensors with each use. However, the controller of the presentdisclosure may be configured with an algorithm to conduct a particularsearch pattern and perform location data processing so as to reduce theeffect of such errors and generate more accurate location information.The search pattern can help to overcome the deficiencies of the hardwareand improve calibration processes so as to allow the use or lessexpensive and less precise sensors while still achieving higher accuracyin location calibration. Such a search pattern and locationdetermination process may be considered in reference to FIGS. 35 and 36.

As illustrated in the two axes example of the grid of FIG. 36, afiducial beacon 36002 is located within a workspace 36000. The searchpattern controlled by the controller may begin by moving the robotichandler from a starting position (e.g., point (1, 1) of the workspace(x, y)). Generally, the handler may be moved along a single axis (e.g.,along the Y axis as illustrated in FIG. 36) while holding the robotichandler (with the auto-learn sensor) at a particular position of theother axis (e.g., a particular position of the X axis). In this example,the handler may then be controlled to advance across the workspacetoward position at point (1, 10) as Y advances from 1 to 10. In theabsence of a detection signal from the auto-learn sensor so as to detecta proximity of the field of the fiducial beacon along this movement, thehandler is then incremented on the other axis to a next position of theworkspace (e.g., point (2, 10) in the example of FIG. 36). The handlermay then be controlled to advance across the workspace toward positionat point (2, 1) in a movement on the same axis while holding theposition on the other axis. In this example, this movement is along theY axis as Y advances from 10 to 1 and X is held at 2. In this way, theadvancing of the robotic handler may be controlled to make repeatedmovements to scan across the workspace to methodically approach apotential fiducial beacon 36002 (or several such beacons) located in theworkspace.

However, the search pattern proceeds differently upon detection of afiducial beacon 36002. For example, during the illustrated searchpattern of FIG. 36, when moving in a first movement 36004 from point (4,10) to point (4, 1) in the example, and toward the fiducial beaconlocated at point (4, 7) as a result of the aforementioned scan, thecontroller, via the sensor, will detect the fiducial beacon and recordan encoder count for the detection during this first movement. (See,e.g., steps 35001 and 35003 of FIG. 35.) In such a case, an encodercount on the Y axis associated with the fiducial beacon may berecorded/saved in a memory when the sensor signal indicates a detectionof the fiducial beacon (e.g., the Hall-effect sensor is triggered by themagnet of the beacon). Such a first detection of the fiducial beaconduring the first movement will then trigger the search pattern toconduct another detection pass of the fiducial beacon by the robotichandler on the same axis but from a different direction. (See, e.g.,steps 35005 and 35007 of FIG. 35.) For example, the handler may continuethe first movement toward grid location (4, 1). The controller thenmoves the robotic handler in a second movement 36006 along the same axisbut in the opposite direction of the first movement such that in theexample, the robotic handler is moved toward the fiducial beacon fromthe opposite direction of the first movement (e.g., toward grid locationat point (4, 10) from grid location at point (4, 1)). During this secondmovement, the controller, with the sensor, will again detect the samefiducial beacon but will record/save in memory another encoder count atthe time of the second detection that occurs during the second movementin the opposite direction of the first movement.

In light of the encoder's precision characteristics and the reliabilitycharacteristics of the auto-learn sensor and fiducial beacon, and eventhough the fiducial beacon is in the same position, this second encodercount may typically be different from the first encoder count. Thus, thecontroller may combine the two recorded counts in order to improve thereliability/accuracy of the determined position along the first axis.For example, the controller may compute/calculate (e.g., step 35009 ofFIG. 35) a further count associated with the actual location of thefiducial beacon using the previously determined counts. For example, theprocessor may calculate an average count from these previouslysensed/determined counts. The calculated count may then be utilized as amore accurate value for the actual location of the fiducial beacon onthe first axis or Y axis (as well as other positions in the workspacethat are derived with a predetermined offset from that calculatedposition associated with the fiducial beacon). As such, the calculatedvalue may serve as a basis for controlling further movements by therobotic handler for sample movement within the workspace. (See, e.g.,step 35011 of FIG. 35.)

In some versions, the position on the other axis of the fiducial beacon(e.g., the second axis or the X axis of FIG. 36) may be simply takenfrom the first movement of the search pattern. In the example of FIG.36, since the sensor detected the fiducial beacon during movementassociated with a constant position (or encoder count) on the X axis,the count associated with that position on the X axis may berecorded/saved as the other axis position of the detected fiducialbeacon. However, optionally, the search pattern may then continue todetect the fiducial beacon with additional movements of the searchpattern such as for determining a more accurate position of the alreadydetected fiducial beacon on the second axis (e.g., the X axis). Forexample, as illustrated in FIG. 36, with another movement 36008, thecontroller may return the robotic handler to the previously detectedfiducial beacon using the calculated count previously mentioned from theY axis and the incrementally determined constant position of the X axisfrom the previous first and second movements of the search pattern. Fromsuch a location, the controller may then move the robotic handler so asto continue the search pattern with a similar approach to the fiducialbeacon from two opposite directions but instead along the X axis.

For example, as illustrated in FIG. 36, while moving the robotic handleralong the X axis but at a constant position of the Y axis associatedwith the previously calculated encoder count, the controller may controlthe robot handler in third movement 36012, such as from point (1, 7) topoint (10, 7) in the illustration. Similarly, the controller may controlthe robot handler in fourth movement 36014 that is opposite the thirdmovement 36012, such as from point (10, 7) to point (1, 7). During eachsuch movements toward the fiducial beacon, the controller may detect thefiducial beacon with the auto-learn sensor and record/save in memory anencoder count from each movement where each encoder count is taken atthe time of the detection of the fiducial beacon during one of the thirdand fourth movements. Having recorded such additional counts, andsimilarly to the methodology previously described, the controller maythen calculate another count from the recorded counts to serve as a moreaccurate position determination of the fiducial beacon 36002 on the Xaxis. For example, the determined encoder counts may be averaged so asto compute a more accurate encoder count that may be attributed to theactual location of the fiducial beacon on the X axis. With suchadditional search pattern operations and the calculation of multipleencoder counts (e.g., one for each robot axis (e.g., X and Y axes)), thecontroller may then more completely and accurately calibrate robotpositions within the workspace based on the known location of thefiducial beacon in the workspace. Moreover, this calibration may beperformed through a repeatable and automatic process without humanintervention.

Although the above example of FIG. 36 describes the detection of singlefiducial beacon, it is understood that the process may similarly operatewith multiple fiducial beacons located in the workspace. In such a case,the search pattern as previously described may then continue to scan theremainder of the workspace until other fiducial beacons are learned(e.g., beacons are detected and accurate locations are similarlydetermined and calculated by repeating the aforementioned steps). Withsuch an automated detection of a set of fiducial beacons (e.g., two,three, four, or more, fiducial beacons 36111, 36112 that may be locatedat different positions of a rack such as three corners of a rack 36020of the workspace), the determined locations may then serve as a basisfor moving the robotic handler within the workspace relative to thedetermined locations.

In some implementations, once several fiducial beacons have beendetected such that their locations on X/Y axes are learned, the systemmay further detect one or more positions on a third axis such as a Zaxis (i.e., a perpendicular axis to the X and Y axes) such as for movingthe robotic handler to positions on the Z axis. For example, in anautomated learning process, a robotic handler may be implemented with asensor to detect a position on the Z axis such as for each of aplurality of fiducial beacons (e.g., two beacons, three beacons ormore). Such a sensor may optionally be a contact sensor (e.g., touch orbump sensor) or other sensor described herein. For example, a controllerof the robotic handler may be programmed to return the handler withsensor to a previously learned X/Y position. At the X/Y position, thehandler may be moved along the Z axis, such as by being lowered towardthe fiducial beacon, to detect a surface of the beacon. The sensor, suchas by contact with the fiducial beacon, may then learn/store the Z axisposition (or a desired offset therefrom), such as with a count of amotor of the robotic handler.

In some versions, such a learning process may be repeated with theplurality of fiducial beacons (e.g., two beacons, three beacons or more)so that controller may interpolate other Z axis positions that have notbeen learned with the fiducial beacon detection process. For example,with two Z axes learned positions, a slope may be calculated with thetwo learned positions in conjunction with the previously learned andrelated X/Y positions. Such a slope could then be indicative of a heightin the work space of the system, such as between the two learnedpositions. The slope may then be used by the controller to control therobotic handler within the three-dimensional workspace (X, Y, Z)relative to the learned positions, such as with a predetermined offsetrelative to an equation of a line with the slope. Optionally, bylearning at least three Z axes positions, an equation for a plane may becalculated with the three learned positions in conjunction with thepreviously learned and related X/Y positions. Such a plane equationcould then be indicative of a height in the work space of the system,such as between the three learned positions. The plane equation may beused by the controller to control the robotic handler within thethree-dimensional workspace (X, Y, Z) relative to the learned positionssuch as with a predetermined offset from the plane. Such detections canbe used in conjunction with variable monolithic planes or Z positionchanges such as to account for large bands of variability with respectto the workspace.

As previously described, although the above example auto-learn sensorand fiducial beacon may be implemented by a Hall-effect sensor andmagnet, other types of fiducial beacons and sensors may be implemented.For example, the auto-learn sensor may be an optical sensor, such as athru-beam optical sensor and the fiducial beacon may include a lightthat is detectable by the optical sensor. Alternatively, the opticalsensor may be a retroreflective photoelectric sensor (a light source anddetector) and the fiducial beacon may be a reflector. In other versions,the sensor may be a capacitive sensor such as for sensing a change incapacitance in proximity with a fiducial beacon or an electricalcontinuity-based sensor such as for sensing contact with a fiducialbeacon.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims. In someinstances, the terminology and symbols may imply specific details thatare not required to practice the technology. For example, although theterms “first” and “second” may be used, unless otherwise specified, theyare not intended to indicate any absolute order but may be utilized todistinguish between distinct elements. Furthermore, although processsteps in the methodologies may be described or illustrated in an order,such an ordering is not required. Those skilled in the art willrecognize that such ordering may be modified and/or aspects thereof maybe conducted concurrently or even synchronously.

1. An apparatus for biological sample preparation, preprocessing and/ordiagnostic assay performed by one or more analyzers of the apparatuscomprising: a fiducial beacon within a workspace of an automatedapparatus for biological sample preparation, preprocessing and/ordiagnostic assay performed by one or more analyzers of the automatedapparatus; a robotic sample handler comprising a first motor and asecond motor for moving the robotic sample handler in the workspace; asensor configured to generate a field detection signal when in a nearvicinity of the fiducial beacon, the sensor adapted to couple with therobotic sample handler; a controller, comprising at least one processor,the controller configured to operate the first and second motors to movethe robotic sample handler in the workspace, the controller configuredto move the robotic sample handler in the workspace in a search pattern,the search pattern comprising first movement along a first axis in afirst direction, the search pattern further comprising a second movementalong the first axis in a second direction, the second directionopposite the first direction; the controller further configured with asensing module to, during the search pattern, (a) receive, via thesensor, the field detection signal produced in a near vicinity of thefiducial beacon, and (b) to determine a first count on the first axiscorrelating with a location of a first detection of the fiducial beaconduring the first movement, and (c) to determine a second count on thefirst axis correlating with a location of a second detection of thefiducial beacon during the second movement; and the controller furtherconfigured with a position calculating module to calculate a third counton the first axis based on the first count and the second count, thethird count correlating with a location of the fiducial beacon on thefirst axis.
 2. The apparatus of claim 1 further comprising: wherein thesearch pattern controlled by the controller further comprises thirdmovement along a second axis in a third direction, the search patternfurther comprising a fourth movement along the second axis in a fourthdirection, the fourth direction opposite the third direction; andwherein the controller with the sensing module is further configured to(a) determine a fourth count on the second axis correlating with alocation of a third detection of the fiducial beacon during the thirdmovement, (b) determine a fifth count on the second axis correlatingwith a location of a fourth detection of the fiducial beacon during thefourth movement; and wherein the controller with the positioncalculating module is further configured to calculate a sixth count onthe second axis based on the fourth count and the fifth count, the sixthcount correlating with a location of the fiducial beacon on the secondaxis.
 3. The apparatus of claim 2 wherein the third count and the sixthcount correspond to x and y coordinates respectively of the location ofthe fiducial beacon in the workspace.
 4. The apparatus of claim 3wherein controller is further configured to control moving the roboticsample handler to predetermined locations in the workspace of theautomated apparatus based on the x and y coordinates of the location ofthe fiducial beacon in the workspace.
 5. The apparatus of claim 2wherein the third count is a first average count calculated by averagingthe first count and the second count and wherein the sixth count is asecond average count calculated by averaging the fourth count and thefifth count.
 6. The apparatus of claim 5 wherein the search patterncomprises a detection of a plurality of fiducial beacons in theworkspace and the controller is configured to calculate coordinates oflocations of the plurality of fiducial beacons, and wherein thecontroller is further configured to control moving, via the controller,the robotic sample handler to predetermined locations in the workspaceof the automated apparatus based on the calculated coordinates of thelocations of the plurality of fiducial beacons in the workspace.
 7. Theapparatus of claim 1 wherein the first count and the second count areproduced by a first encoder of the first motor.
 8. The apparatus ofclaim 7, when dependent on claim 2, wherein the fourth count and thefifth count are produced by a second encoder of the second motor.
 9. Theapparatus of claim 1 wherein the fiducial beacon produces a magneticfield.
 10. The apparatus of claim 1 wherein the fiducial beacon includesa magnetic.
 11. The apparatus of claim 1 wherein the sensor is aHall-effect sensor.
 12. The apparatus of claim 1 wherein the roboticsample handler is a gripper.
 13. The apparatus of claim 12 wherein thesensor is adapted as a removeable sensor for insertion into the gripperduring the search pattern.
 14. A processor-readable medium, havingstored thereon processor-executable instructions which, when executed bya processor, cause the processor to control operation of a controller ofa robotic handler, the robotic handler including a sensor configured togenerate a field detection signal when in a near vicinity of a fiducialbeacon in a workspace of an automated apparatus for biological samplepreparation, preprocessing and/or diagnostic assay performed by one ormore analyzers of the automated apparatus, the processor-executableinstructions comprising: a control module configured to control moving,via the controller, the robotic handler in the workspace of theautomated apparatus, the moving comprising a search pattern, the searchpattern comprising first movement along a first axis in a firstdirection, the search pattern further comprising a second movement alongthe first axis in a second direction, the second direction opposite thefirst direction; a sensing module configured to control, during thesearch pattern, receiving, via the sensor coupled to the robotichandler, the field detection signal produced in a near vicinity of thefiducial beacon, the sensing module configured to determine a firstcount on the first axis correlating with a location of a first detectionof the fiducial beacon during the first movement, the sensing modulefurther configured to determine a second count on the first axiscorrelating with a location of a second detection of the fiducial beaconduring the second movement; and a position calculating module configuredto calculate a third count on the first axis based on the first countand the second count, the third count correlating with a location of thefiducial beacon on the first axis.
 15. The processor-readable medium ofclaim 14 further comprising: wherein the search pattern controlled bythe control module further comprises third movement along a second axisin a third direction, the search pattern further comprising a fourthmovement along the second axis in a fourth direction, the fourthdirection opposite the third direction; and wherein the sensing moduleis further configured to determine a fourth count on the second axiscorrelating with a location of a third detection of the fiducial beaconduring the third movement, the sensing module further configured todetermine a fifth count on the second axis correlating with a locationof a fourth detection of the fiducial beacon during the fourth movement;and wherein the position calculating module is further configured tocalculate a sixth count on the second axis based on the fourth count andthe fifth count, the sixth count correlating with a location of thefiducial beacon on the second axis.
 16. The processor-readable medium ofclaim 15 wherein the third count and the sixth count correspond to x andy coordinates respectively of the location of the fiducial beacon in theworkspace.
 17. The processor-readable medium of claim 16 wherein thecontrol module is further configured to control moving, via thecontroller, the robotic handler to predetermined locations in theworkspace of the automated apparatus based on the x and y coordinates ofthe location of the fiducial beacon in the workspace.
 18. Theprocessor-readable medium of claim 15 wherein the third count is a firstaverage count calculated by averaging the first count and the secondcount and wherein the sixth count is a second average count calculatedby averaging the fourth count and the fifth count.
 19. Theprocessor-readable medium of claim 14 wherein the search patterncomprises a detection of a plurality of fiducial beacons in theworkspace and wherein the position calculating module is configured tocalculate coordinates for locations of the plurality of fiducialbeacons, and wherein the control module is further configured to controlmoving, via the controller, the robotic handler to predeterminedlocations in the workspace of the automated apparatus based on thecalculated coordinates of locations of the plurality of fiducial beaconsin the workspace.
 20. The processor-readable medium of claim 14 whereinthe first count and the second count are produced by a first encoder ofa first motor controlled by the controller that is configured to movethe robotic handler in the workspace.
 21. The processor-readable mediumof claim 20, when dependent on claim 15, wherein the fourth count andthe fifth count are produced by an encoder of a second motor controlledby the controller that is configured to move the robotic handler in theworkspace.
 22. The processor-readable medium of claim 14 wherein thefiducial beacon produces a magnetic field.
 23. The processor-readablemedium of claim 14 wherein the fiducial beacon includes a magnetic. 24.The processor-readable medium of claim 14 wherein the sensor is aHall-effect sensor.
 25. A method of a controller to control operation ofa robotic handler, the robotic handler including a sensor configured togenerate a field detection signal when in a near vicinity of a fiducialbeacon in a workspace of an automated apparatus for biological samplepreparation, preprocessing and/or diagnostic assay performed by one ormore analyzers of the automated apparatus, the method comprising:controlling moving of the robotic handler in the workspace of theautomated apparatus in a search pattern, the search pattern comprisingfirst movement along a first axis in a first direction; sensing, duringthe first movement of the search pattern, so as to receive, via thesensor coupled to the robotic handler, the field detection signalproduced in a near vicinity of the fiducial beacon, and to determine afirst count on the first axis correlating with a location of a firstdetection of the fiducial beacon during the first movement, controllingmoving of the robotic handler in the workspace of the automatedapparatus in the search pattern, the search pattern comprising a secondmovement along the first axis in a second direction, the seconddirection opposite the first direction; sensing, during the secondmovement of the search pattern, so as to receive, via the sensor coupledto the robotic handler, the field detection signal produced in a nearvicinity of the fiducial beacon, and to determine a second count on thefirst axis correlating with a location of a second detection of thefiducial beacon during the second movement; and calculating a thirdcount on the first axis based on the first count and the second count,the third count correlating with a location of the fiducial beacon onthe first axis.
 26. The method of claim 25 further comprisingcontrolling moving of the robotic handler to one or more predeterminedlocations in the workspace of the automated apparatus based on thecalculated third count correlating with the location of the fiducialbeacon in the workspace.